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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69448

179 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 08, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Customed, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

179 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 179

Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0237-2015
Recall number
Z-0237-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
185000

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 111102811 111112953 111112969 111123257 111123438 112010003 112020291 112030762 112041051 112041384 112051641 112051718 112062298 112072758 112083040 112104122 112104289 112114540 112124364 112124885 113025838 113026102 113026206 113057390 113057682 113099556 131010023 131210663 140111103 140412874 140513047 140513388 140613946 140714499 140815022

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 2 of 179

Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0238-2015
Recall number
Z-0238-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
76800

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111112971 111123273 112010006 112020294 112030797 112041052 112041386 112041450 112051644 112062300 112083043 112093635 113025799 113025979 113026274 113036446 113046993 113047330 113057829 113068135 113078452 113078659 113099261 131110143 140111104 140211714 140312032 140412568 140513034 140613550 140814606 140815025

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 3 of 179

Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0239-2015
Recall number
Z-0239-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
8000

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111123439 111123477 112030810 112041388 112051661 112072578 140211712 140513053

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 4 of 179

Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0240-2015
Recall number
Z-0240-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
66250

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111112932 111123285 112010264 112030760 112041053 112051645 112062307 112083045 112093740 112104126 112114893 113025998 113046869 113078228 113078662 113099263 131110063 131210669 140111107 140211528 140412569 140412798 140613556 140714140 140815029

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 5 of 179

Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0241-2015
Recall number
Z-0241-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
12300

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111112975 112020298 112030800 112062308 131010025 131210852 140211529 140513036 140714141

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 6 of 179

Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0242-2015
Recall number
Z-0242-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
78600

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111102823 111112980 111123314 111123440 112020308 112020361 112030826 112041369 112041434 112051646 112062317 112083160 112093741 112104363 112124894 113015487 113035832 113046996 113047144 113057604 113057810 113078456 113078674 113089014 113109706 131110154 131110288 131210677 140111108 140211531 140312046 140412578 140513065 140613570 140714155 140714430 140814942

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 7 of 179

Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0243-2015
Recall number
Z-0243-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
134160

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111113095 111123232 112010156 112020472 112030761 112041313 112062452 112072959 112082969 112083427 112104362 112114536 112124889 113026115 113036350 113036799 113047312 113068166 113109823 131110258 131210686 140312144 140412667 140513046 140613603 140714263 140814789 140915159

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 8 of 179

Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0244-2015
Recall number
Z-0244-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
50950

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111113096 111123429 112020157 112020479 112030817 112041410 112051447 112062453 112072960 112083428 112093754 113067870 113068167 113088807 113099431 131110259 131210687 140111124 140211538 140412668 140613604 140714264 140814790 140915160

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 9 of 179

Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0245-2015
Recall number
Z-0245-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
89284

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111103264 112010182 112020504 112030803 112041055 112051992 112062557 112062558 112072803 112093630 112104254 112104360 112114532 112114896 112125100 113026195 113036464 113036803 113057608 113057848 113068173 113088872 113089076 113109851 131210264 131210653 140111125 140211539 140312172 140312383 140513369 140714294 140714515 140814956 140915480

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 10 of 179

Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0246-2015
Recall number
Z-0246-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
86912

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111103265 111113126 112010183 112020505 112030804 112041056 112051993 112072804 112093631 112104361 112104533 112124897 113026196 113036804 113057491 113067873 113078333 113088873 113099438 113109852 131110265 131210654 140111126 140211540 140312173 140312384 140513370 140714295 140814813 140814957 140915481

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 11 of 179

Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0247-2015
Recall number
Z-0247-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
13680

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 112020506 112030882 112062454 112093946 112114888 113047160 113068174 113109854 131210826 140211849 140412693 140613605 140915161

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 12 of 179

Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0248-2015
Recall number
Z-0248-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
9700

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 112051996 112114535 113025779 113078335 113099443 140111073 140412695 140613606 140714299

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 13 of 179

Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0249-2015
Recall number
Z-0249-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
9200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111123296 112030746 112124854 112124886 113036382 113088890 131110313 140412880 140613780 140915163

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 14 of 179

Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0250-2015
Recall number
Z-0250-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
20960

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111112954 111112965 111123297 111123444 112010204 112020511 112030694 112051651 112052014 112083064 112093637 112104287 112114538 112124884 113025834 113026068 113036743 113047031 113057506 113067936 113067964 140111127 140312184 140513161 140613781 140814822 1130688891

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 15 of 179

Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0251-2015
Recall number
Z-0251-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
27024

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111112986 111123441 112010278 112041183 112051733 112062333 112093745 112104134 113026216 113047151 113068038 113078678 131110157 140111110 140312050 140513069 140814630 1130154790

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 16 of 179

Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0252-2015
Recall number
Z-0252-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
28020

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111112987 112010275 112030830 112041392 112051737 112062338 112072827 112093746 113015492 113026217 113047317 113068142 113109711 140111111 140312056 140513037 140714161 140915150

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 17 of 179

Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0253-2015
Recall number
Z-0253-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
4710

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 113046906 140412564 140513040 140814664

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 18 of 179

Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0254-2015
Recall number
Z-0254-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
23300

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 11123442 111112934 112041187 112051647 112051758 112062415 112072773 112083390 113026043 113026103 113026229 113057384 113068146 113078701 113109725 140613855 140814650

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 19 of 179

Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0255-2015
Recall number
Z-0255-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
3540

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 112010064 112062429 112072429 113015552 113078579 140211537 140613802 140714188 140814663

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 20 of 179

Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0256-2015
Recall number
Z-0256-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
66200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111113039 111123389 112010093 112020412 112030646 112041203 112051652 112051882 112062451 112062568 112093753 112114887 113036455 113047208 113057433 113057863 113078277 113088761 113099393 113109754 131110201 131210683 131210763 140111120 140312090 140512615 140513043 140613601 140613631 1121114534

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 21 of 179

Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0257-2015
Recall number
Z-0257-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
10090

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111103390 112041455 112062288 112093634 113046894 113088762 140111121 140111176 140814743

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 22 of 179

Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0258-2015
Recall number
Z-0258-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
4000

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 111123478 112041407 113047224 113109998

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 23 of 179

Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0259-2015
Recall number
Z-0259-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
170

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 112104267

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 24 of 179

Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0260-2015
Recall number
Z-0260-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
2640

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 113036397

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 25 of 179

Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0261-2015
Recall number
Z-0261-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
2520

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 113036399

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 26 of 179

Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0262-2015
Recall number
Z-0262-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1120

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 113036400

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 27 of 179

Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0263-2015
Recall number
Z-0263-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
2240

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers: 113036395

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 28 of 179

Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0264-2015
Recall number
Z-0264-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
2670

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 113036396

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 29 of 179

Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0265-2015
Recall number
Z-0265-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1152

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513048 140613547 140714116

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 30 of 179

O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0266-2015
Recall number
Z-0266-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
176

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513051 140613549 140714119 140814605 140815024

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 31 of 179

Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0267-2015
Recall number
Z-0267-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1152

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513052 140513243 140613806 140714400

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 32 of 179

Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0268-2015
Recall number
Z-0268-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
840

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513056 140513343 140613807 140814832 140814874

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 33 of 179

Cysto Tur Pack, Catalog number 900-080. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0269-2015
Recall number
Z-0269-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
380

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412449 140513057 140613558 140714144 140814613 140815030

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 34 of 179

OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0270-2015
Recall number
Z-0270-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
224

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513060 140714150 140814622

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 35 of 179

Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0271-2015
Recall number
Z-0271-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
180

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412451 140513061 140613568 140714151 140814623

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 36 of 179

Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0272-2015
Recall number
Z-0272-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
480

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513062 140513474 140613801 140613808 140714385

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 37 of 179

Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0273-2015
Recall number
Z-0273-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
162

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513473 140714152 140714428

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 38 of 179

Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0274-2015
Recall number
Z-0274-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
256

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513063 140513390 140613948 140714429 140814966 140915118

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 39 of 179

Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0275-2015
Recall number
Z-0275-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
740

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513064 140513451 140613809 140714386 140814882 140915230

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 40 of 179

Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0276-2015
Recall number
Z-0276-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
9770

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513066 140513253 140613811 140714388 140915251

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 41 of 179

Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0277-2015
Recall number
Z-0277-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1500

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613812

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 42 of 179

Neuro Pack, Catalog number 900-1146. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0278-2015
Recall number
Z-0278-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
132

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140211777 140513068 140513475 140714157 140814629

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 43 of 179

Laparoscopy Pack, Catalog number 900-1176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0279-2015
Recall number
Z-0279-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
156

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513071 140513476 140714159 140814602 140915119

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 44 of 179

Laparoscopy OB GYN Pack, Catalog number 900-1192. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0280-2015
Recall number
Z-0280-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
105

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513072 140513334 140614028 140714508 140915120

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 45 of 179

Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0281-2015
Recall number
Z-0281-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
71

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513169 140613799 140714322 140814871

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 46 of 179

Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0282-2015
Recall number
Z-0282-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
180

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140211633 140513335 140513452 140614072 140714431

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 47 of 179

Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0283-2015
Recall number
Z-0283-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
150

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412594 140513078 140513477 140714172 140814642 140814732

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 48 of 179

Premium Laparotomy Pack, Catalog number 900-1296. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0284-2015
Recall number
Z-0284-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1020

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513344 140613813 140714389 140814943

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 49 of 179

Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0285-2015
Recall number
Z-0285-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
335

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513080 140513459 140613814 140714432 140814944

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 50 of 179

Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0286-2015
Recall number
Z-0286-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
207

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513082 140613588 140614074 140714502 140814970

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 51 of 179

Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0287-2015
Recall number
Z-0287-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
56

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613591 140714175 140814645

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 52 of 179

Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0288-2015
Recall number
Z-0288-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
108

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613718 140714321 140814870 140815034

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 53 of 179

Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0289-2015
Recall number
Z-0289-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
40

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513083 140814646

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 54 of 179

Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0290-2015
Recall number
Z-0290-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
48

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513084 140613592 140714177

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 55 of 179

Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0291-2015
Recall number
Z-0291-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
48

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412872 1405133354 140513354 140613716 140613945 140814327 140914990

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 56 of 179

Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0292-2015
Recall number
Z-0292-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
315

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513089 140613856 140614076 140814651 140814971

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 57 of 179

D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0293-2015
Recall number
Z-0293-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
108

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613857 140814652 140915231

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 58 of 179

ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0294-2015
Recall number
Z-0294-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
140

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513090 140613609 140714182 140814653

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 59 of 179

Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0295-2015
Recall number
Z-0295-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
70

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513091 140613610 140714183 140814654

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 60 of 179

Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0296-2015
Recall number
Z-0296-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
892

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412830 140513345 140613815 140714436

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 61 of 179

D&C Laparoscopy Pack, Catalog number 900-1496. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0297-2015
Recall number
Z-0297-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
176

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513092 140513391 140613611 140614079 140714437

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 62 of 179

Cirugia Cardiovascular Case Cart, Catalog number 900-1500. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0298-2015
Recall number
Z-0298-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
48

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412871 140613717 140614025 140714326 140814867 140814991

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 63 of 179

Urology Pack, Catalog number 900-1521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0299-2015
Recall number
Z-0299-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
284

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513346 140613816 140714533

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 64 of 179

Dressing Change, Catalog number 900-1538. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0300-2015
Recall number
Z-0300-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1050

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412914 140613614 140714185

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 65 of 179

Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0301-2015
Recall number
Z-0301-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
156

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140312077 140412454 140613617 140714189 140814665 140915233

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 66 of 179

Retina Pack, Catalog number 900-1611. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0302-2015
Recall number
Z-0302-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
84

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

(4 lots) Lot numbers 140513000 140613621 140714194 140814670

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 67 of 179

Femoral Pack, Catalog number 900-164. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0303-2015
Recall number
Z-0303-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
270

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513392 140513453 140613818 140814735 140814878

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 68 of 179

Labor & Delivery Pack, Catalog number 900-168. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0304-2015
Recall number
Z-0304-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
352

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513102 140513461 140714196 140814534 140814736 140814972

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 69 of 179

Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0305-2015
Recall number
Z-0305-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
246

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513103 140513462 140613819 140814603

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 70 of 179

Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0306-2015
Recall number
Z-0306-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
126

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513104 140513464 140613820

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 71 of 179

Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0307-2015
Recall number
Z-0307-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
160

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513106 140513245 140613821 140714336 140814672 140814948

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 72 of 179

Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0308-2015
Recall number
Z-0308-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
180

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513108 140613625 140714199 140814673 140915236

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 73 of 179

OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0309-2015
Recall number
Z-0309-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
120

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513109 140613626 140714200 140814737

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 74 of 179

Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0310-2015
Recall number
Z-0310-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
76

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513110 140613628 140814738

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 75 of 179

Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0311-2015
Recall number
Z-0311-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
625

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513347 140613822 140714391

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 76 of 179

Urology Pack, Catalog number 900-1738. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0312-2015
Recall number
Z-0312-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
40

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140211651 140312085 140714201 140915241

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 77 of 179

Urology Pack, Catalog number 900-1742. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0313-2015
Recall number
Z-0313-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
60

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513111 140513393 140613803 140814739

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 78 of 179

Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0314-2015
Recall number
Z-0314-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
2520

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513112 140613823 140714531 140814706

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 79 of 179

Ophtalmic Pack, Catalog number 900-1780. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0315-2015
Recall number
Z-0315-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
582

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513114 140513454 140613824 140714334

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 80 of 179

Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0316-2015
Recall number
Z-0316-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
28

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513115 140613633 140714207

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 81 of 179

Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0317-2015
Recall number
Z-0317-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
12

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613947

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 82 of 179

Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0318-2015
Recall number
Z-0318-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
36

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613638 140814751

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 83 of 179

Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0319-2015
Recall number
Z-0319-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
96

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513465

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 84 of 179

Universal Pack, Catalog number 900-1936. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0320-2015
Recall number
Z-0320-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
45

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection..

Code information

Lot numbers 140412891 140613640 140714213

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 85 of 179

Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0321-2015
Recall number
Z-0321-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
35

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513455

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 86 of 179

Higado & Pancrea Pack, Catalog number 900-1966. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0322-2015
Recall number
Z-0322-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
160

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513119 140613951 140714510

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 87 of 179

Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0323-2015
Recall number
Z-0323-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
57

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513120 140613644 140714218 140814755

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 88 of 179

Orthopedic tray, Catalog number 900-1985 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0324-2015
Recall number
Z-0324-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
36

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140814757 140915244

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 89 of 179

Laparoscopy Chole Pack, Catalog number 900-2004. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0325-2015
Recall number
Z-0325-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
36

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613472

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 90 of 179

Angiography Pack, Catalog number 900-2038. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0326-2015
Recall number
Z-0326-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
212

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140111450 140513123 140613860 140714392

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 91 of 179

Angiography Pack, catalog #900-210 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0327-2015
Recall number
Z-0327-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1068

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Catalog number 900-210 (4 lots) Lot numbers 140513348 140613829 140714402 140814873

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 92 of 179

Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0328-2015
Recall number
Z-0328-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
144

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513124 140613657 140714232 140814767

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 93 of 179

Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0329-2015
Recall number
Z-0329-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
92

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412645 140513125 140613658 140714233 140714335

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 94 of 179

Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0330-2015
Recall number
Z-0330-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
460

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513126 140513397 140613659 140714234 140814768 140915245

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 95 of 179

Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0331-2015
Recall number
Z-0331-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
270

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513127 140613830 140714540 140814769

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 96 of 179

Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0332-2015
Recall number
Z-0332-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
880

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513478 140714235 140714541 140814982

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 97 of 179

Ear Pack, catalog #900-2234 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0333-2015
Recall number
Z-0333-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
105

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412835 140512993 140613955 140714236 140814770

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 98 of 179

Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0334-2015
Recall number
Z-0334-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
114

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513128 140613720 140714240 140814775 140915247

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 99 of 179

Laparoscopy Colorectal Surgical Pack, catalog #900-2259A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0335-2015
Recall number
Z-0335-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
280

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412651 140612902 140714241 140915248

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 100 of 179

General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0336-2015
Recall number
Z-0336-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
308

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140312128 140412652 140613722 140714242 140814776

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 101 of 179

Vaginal Procedure Pack, catalog #900-2385 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0337-2015
Recall number
Z-0337-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
8

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613805

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 102 of 179

Total Hysterectomy, catalog #900-2415 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0338-2015
Recall number
Z-0338-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
6

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412654

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 103 of 179

Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0339-2015
Recall number
Z-0339-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
92

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140512912 140613725

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 104 of 179

Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0340-2015
Recall number
Z-0340-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
400

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513219 140714247

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 105 of 179

Arthroscopy Pack, catalog #900-2473 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0341-2015
Recall number
Z-0341-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513400

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 106 of 179

Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0342-2015
Recall number
Z-0342-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
200

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140714248

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 107 of 179

Laparoscopy and Pack (1)(2), catalog #900-2483 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0343-2015
Recall number
Z-0343-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
240

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513401 140714249

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 108 of 179

Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0344-2015
Recall number
Z-0344-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
400

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613956 140714512

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 109 of 179

Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0345-2015
Recall number
Z-0345-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
204

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513220 140714250

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 110 of 179

Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0346-2015
Recall number
Z-0346-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
400

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513131 140613726 140714251 140814779

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 111 of 179

Urology Pack, catalog #900-2510 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0347-2015
Recall number
Z-0347-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
222

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412657 140513132 140613727 140714252 140814780

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 112 of 179

Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0348-2015
Recall number
Z-0348-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
944

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412658 140513479 140613831 140714542 140814781

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 113 of 179

Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0349-2015
Recall number
Z-0349-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
64

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140814782

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 114 of 179

OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0350-2015
Recall number
Z-0350-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
80

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140714253 140814783

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 115 of 179

Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0351-2015
Recall number
Z-0351-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
144

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513355 140613728 140714254 140814784

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 116 of 179

Arthroscopy Pack, catalog #900-2609 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0352-2015
Recall number
Z-0352-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
75

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412660 140513133 140513402 140613957 140714513 140915132

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 117 of 179

Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0353-2015
Recall number
Z-0353-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
129

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140312137 140513134 140613729

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 118 of 179

Extremity PACK, catalog #900-2615 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0354-2015
Recall number
Z-0354-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
168

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513135 140613730 140714256

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 119 of 179

Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0355-2015
Recall number
Z-0355-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
96

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140312139 140412663 140513136 140613731

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 120 of 179

Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0356-2015
Recall number
Z-0356-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
106

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513137 140814869

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 121 of 179

Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0357-2015
Recall number
Z-0357-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140814938

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 122 of 179

Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0358-2015
Recall number
Z-0358-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
6

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140714517

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 123 of 179

Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0359-2015
Recall number
Z-0359-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
50

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140814785

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 124 of 179

Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0360-2015
Recall number
Z-0360-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
160

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140512992 140613733 140714260 140814786

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 125 of 179

Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0361-2015
Recall number
Z-0361-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
126

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140312143 140412666 140513139 140613734 140714262 140814788

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 126 of 179

Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0362-2015
Recall number
Z-0362-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
852

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412669 140412796 140613735 140714265

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 127 of 179

Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0363-2015
Recall number
Z-0363-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
288

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513140 140613736 140714266 140814791

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 128 of 179

Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0364-2015
Recall number
Z-0364-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
300

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140714267 140814792

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 129 of 179

Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0365-2015
Recall number
Z-0365-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
128

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513141 140613737 140714268 140814793

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 130 of 179

ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0366-2015
Recall number
Z-0366-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
6

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140714524

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 131 of 179

Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0367-2015
Recall number
Z-0367-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
51

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140312147 140613795 140714523

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 132 of 179

Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0368-2015
Recall number
Z-0368-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
60

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613794 140714522 140915137

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 133 of 179

Tummy Tuck Pack, Catalog #900-3026 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0369-2015
Recall number
Z-0369-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
18

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140714520

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 134 of 179

Liposuction Pack, Catalog #900-3028 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0370-2015
Recall number
Z-0370-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613790 140714518

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 135 of 179

Breast Pack Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0371-2015
Recall number
Z-0371-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
36

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613789 140714519

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 136 of 179

Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0372-2015
Recall number
Z-0372-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
20

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613791 140714521

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 137 of 179

Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0373-2015
Recall number
Z-0373-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
96

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513143 140714276

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 138 of 179

Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0374-2015
Recall number
Z-0374-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
240

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513356 140613743 140714277 140814798

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 139 of 179

Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0375-2015
Recall number
Z-0375-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
63

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513333 140914937

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 140 of 179

Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0376-2015
Recall number
Z-0376-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
242

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513144 140513338 140613746 140613832 140814544

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 141 of 179

Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0377-2015
Recall number
Z-0377-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
654

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513246 140613833 140714545 140814876

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 142 of 179

Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0378-2015
Recall number
Z-0378-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1680

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513247 140613834 140714393 140814875

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 143 of 179

Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0379-2015
Recall number
Z-0379-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
260

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513349 140714284 140814546

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 144 of 179

Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0380-2015
Recall number
Z-0380-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
440

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513363 140613756 140613835 140714394

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 145 of 179

Labor & Delivery Pack, Catalog number 900-419. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0381-2015
Recall number
Z-0381-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
344

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140211670 140311939 140613759 140714547

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 146 of 179

Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0382-2015
Recall number
Z-0382-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
75

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140111229 140613760 140714287

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 147 of 179

Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0383-2015
Recall number
Z-0383-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
250

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513248 140613761 140613837

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 148 of 179

Laparoscopy Pack, Catalog number 900-474. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0384-2015
Recall number
Z-0384-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
240

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513480 140613838 140814548 140814955

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 149 of 179

Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0385-2015
Recall number
Z-0385-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
48

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140613763 140714289

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 150 of 179

Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0386-2015
Recall number
Z-0386-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
126

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513249 140613839 140814809

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 151 of 179

Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0387-2015
Recall number
Z-0387-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
70

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513372 140915211

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 152 of 179

Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0388-2015
Recall number
Z-0388-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
354

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140312022 140412694 140613769 140714298 140714332 140814677 140814940

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 153 of 179

Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0389-2015
Recall number
Z-0389-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
192

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513373 140613770 140614115 140714333 140814678 140915190

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 154 of 179

Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0390-2015
Recall number
Z-0390-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
160

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513375 140613772 140714301 140814679 140915208

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 155 of 179

Angiography Pack, Catalog number 900-610. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0391-2015
Recall number
Z-0391-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
210

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513221 140613773 140714302 140814680

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 156 of 179

Arthroscopy Pack, Catalog number 900-620. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0392-2015
Recall number
Z-0392-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
340

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513377 140513456 140613840 140714396

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 157 of 179

O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0393-2015
Recall number
Z-0393-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
550

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513154 140613796 140915134

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 158 of 179

Fanfold Drape, Catalog number 900-633. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0394-2015
Recall number
Z-0394-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
6300

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513350 140613841 140714395 140814959 140815096

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 159 of 179

Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0395-2015
Recall number
Z-0395-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
475

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513250 140613842 140714397 140814960

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 160 of 179

O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0396-2015
Recall number
Z-0396-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
420

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513351 140613843 140814682 140814880

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 161 of 179

Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0397-2015
Recall number
Z-0397-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
490

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513352 140613844 140714398 140814879

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 162 of 179

Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0398-2015
Recall number
Z-0398-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
400

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412700 140412908 140613778 140714305 140814550 140915204

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 163 of 179

Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0399-2015
Recall number
Z-0399-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
660

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140312026 140412702 140513380 140513481 140714306 140814551 140814961

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 164 of 179

Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0400-2015
Recall number
Z-0400-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
36

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513381 140613779

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 165 of 179

General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0401-2015
Recall number
Z-0401-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
680

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513251 140613847 140714399 140814962

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 166 of 179

Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0402-2015
Recall number
Z-0402-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
236

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513145 140513340 140613848 140814683 140915202

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 167 of 179

Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0403-2015
Recall number
Z-0403-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
288

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513146 140513482 140714310 140814684

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 168 of 179

Cesarean Pack, Catalog # 900-851 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0404-2015
Recall number
Z-0404-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
264

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513147 140513483 140613782 140714311 140814685

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 169 of 179

Urology Pack, Catalog # 900-868 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0405-2015
Recall number
Z-0405-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
195

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513484 140613783 140714312 140814686

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 170 of 179

Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0406-2015
Recall number
Z-0406-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
60

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140412917 140513342 140614032 140915195

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 171 of 179

, Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0407-2015
Recall number
Z-0407-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
100

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140714315 140814826 140915194

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 172 of 179

Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0408-2015
Recall number
Z-0408-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
105

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513470 140714316

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 173 of 179

C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0409-2015
Recall number
Z-0409-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
600

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513148 140513469 140613849 140714552 140814963

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 174 of 179

Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0410-2015
Recall number
Z-0410-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
1140

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513353 140613850 140714553 140814881 140815097

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 175 of 179

Strabismus And Plastic Pack, Catalog # 900-946 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0411-2015
Recall number
Z-0411-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
120

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513384 140613786 140714318 140814828 140915190

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 176 of 179

Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0412-2015
Recall number
Z-0412-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
120

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140714319 140814829 140915189

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 177 of 179

Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0413-2015
Recall number
Z-0413-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
372

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513385 140513485 140613851 140814554 140814964 140915188

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 178 of 179

Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0414-2015
Recall number
Z-0414-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
230

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513386 140613787 140714320 140814830 140915187

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..

device · product 179 of 179

C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-0415-2015
Recall number
Z-0415-2015
Initiated
October 08, 2014
Classification
Class I
Status
Terminated
Recalling firm
Customed, Inc
Quantity
122

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Code information

Lot numbers 140513471 140613852 140814555

Distribution pattern

US Distribution to Florida, New York and Puerto Rico..