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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76255

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

Open FDA event record

Event summary

Timeline bucket
January 09, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Resource Optimization & Innovation Llc

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

135 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 135

Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland

Z-1544-2017
Recall number
Z-1544-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
41 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037222C Exp Date 2018-08-05; 039975C Exp Date 2018-12-02;

Distribution pattern

US Distribution to LA and TX.

device · product 2 of 135

Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels

Z-1545-2017
Recall number
Z-1545-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
46 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029663A Exp Date: 2017-10-30; 031173A Exp Date 2018-01-25; 032155A Exp Date: 2018-02-28;

Distribution pattern

US Distribution to LA and TX.

device · product 3 of 135

Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa

Z-1546-2017
Recall number
Z-1546-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
210 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

036887C Exp Date: 2018-07-28; 038469C Exp Date 2018-09-26;

Distribution pattern

US Distribution to LA and TX.

device · product 4 of 135

Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa

Z-1547-2017
Recall number
Z-1547-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
90 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037598B Exp Date: 2018-07-30;

Distribution pattern

US Distribution to LA and TX.

device · product 5 of 135

Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn

Z-1548-201
Recall number
Z-1548-201
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
2,122 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029388C Exp Date: 2017-11-09; 030253C Exp Date: 2017-12-30; 032103C Exp Date: 2018-03-07; 033169C Exp Date: 2018-04-26; 034466C Exp Date: 2018-06-22;

Distribution pattern

US Distribution to LA and TX.

device · product 6 of 135

Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn

Z-1549-2017
Recall number
Z-1549-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
208 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038643C Exp Date 2018-10-05; 039774C Exp Date 2018-11-23

Distribution pattern

US Distribution to LA and TX.

device · product 7 of 135

Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa

Z-1550-201
Recall number
Z-1550-201
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
55 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028743B Exp Date 2017-03-30; 030250B Exp Date 2017-08-01

Distribution pattern

US Distribution to LA and TX.

device · product 8 of 135

Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn

Z-1551-2017
Recall number
Z-1551-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
112 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026390A Exp Date 2017-07-13;

Distribution pattern

US Distribution to LA and TX.

device · product 9 of 135

Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU

Z-1552-2017
Recall number
Z-1552-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
6 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027914A Exp Date 2017-08-30;

Distribution pattern

US Distribution to LA and TX.

device · product 10 of 135

Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills

Z-1553-2017
Recall number
Z-1553-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
420 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033493D Exp Date 2018-05-10; 035015D Exp Date 2018-07-12

Distribution pattern

US Distribution to LA and TX.

device · product 11 of 135

Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis

Z-1554-2017
Recall number
Z-1554-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
320 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037143E Exp Date 2018-08-05; 038259E Exp Date 2018-09-19; 040326E Exp Date 2018-12-14;

Distribution pattern

US Distribution to LA and TX.

device · product 12 of 135

Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels

Z-1555-2017
Recall number
Z-1555-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
88 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026556B Exp Date 2017-07-20; 029081B Exp Date 2017-10-23; 031679B Exp Date 2018-02-19; 032434B Exp Date 2018-03-24; 033616B Exp Date 2018-05-13;

Distribution pattern

US Distribution to LA and TX.

device · product 13 of 135

Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels

Z-1556-2017
Recall number
Z-1556-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
46 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034433C Exp Date 2018-06-21; 039905C Exp Date 2018-12-01; 040125C Exp Date 2018-12-08;

Distribution pattern

US Distribution to LA and TX.

device · product 14 of 135

Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU

Z-1557-2017
Recall number
Z-1557-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
16 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029000B Exp Date 2017-09-30; 029744B Exp Date 2017-09-30;

Distribution pattern

US Distribution to LA and TX.

device · product 15 of 135

Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU

Z-1558-2017
Recall number
Z-1558-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
14 Kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030874C Exp Date 2017-09-30; 032520C Exp Date 2017-09-30;

Distribution pattern

US Distribution to LA and TX.

device · product 16 of 135

Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU

Z-1559-2017
Recall number
Z-1559-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
156 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027749A Exp Date 2017-08-21; 028525A Exp Date 2017-10-02; 029878A Exp Date 2017-10-30; 032596A Exp Date 2018-02-28; 034309A Exp Date 2018-06-17; 035003A Exp Date 2018-07-11;

Distribution pattern

US Distribution to LA and TX.

device · product 17 of 135

Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU

Z-1560-2017
Recall number
Z-1560-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
30 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037321B Exp Date 2018-08-12

Distribution pattern

US Distribution to LA and TX.

device · product 18 of 135

Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU

Z-1561-2017
Recall number
Z-1561-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
42 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038795C Exp Date 2018-10-11

Distribution pattern

US Distribution to LA and TX.

device · product 19 of 135

Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU

Z-1562-2017
Recall number
Z-1562-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
1,548 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026446A Exp Date 2017-07-16; 030247A Exp Date 2017-12-28; 032384A Exp Date 2018-03-22; 033038A Exp Date 2018-04-20; 034310A Exp Date 2018-06-17;

Distribution pattern

US Distribution to LA and TX.

device · product 20 of 135

Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU

Z-1563-2017
Recall number
Z-1563-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
48 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030249E Exp Date 2017-07-30; 031452E Exp Date 2017-07-30;

Distribution pattern

US Distribution to LA and TX.

device · product 21 of 135

Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU

Z-1564-2017
Recall number
Z-1564-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
27 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033453G Exp Date 2018-04-30;

Distribution pattern

US Distribution to LA and TX.

device · product 22 of 135

Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU

Z-1565-2017
Recall number
Z-1565-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
16 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

036916H Exp Date 2018-04-30;

Distribution pattern

US Distribution to LA and TX.

device · product 23 of 135

Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU

Z-1566-2017
Recall number
Z-1566-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
32 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

039472I Exp Date 2018-04-30;

Distribution pattern

US Distribution to LA and TX.

device · product 24 of 135

Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU

Z-1567-2017
Recall number
Z-1567-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
28 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

031483A Exp Date 2017-02-27; 034832A Exp Date 2017-12-03;

Distribution pattern

US Distribution to LA and TX.

device · product 25 of 135

Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU

Z-1568-2017
Recall number
Z-1568-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
26 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037932B Exp Date 2018-05-12; 039334B Exp Date 2018-07-21;

Distribution pattern

US Distribution to LA and TX.

device · product 26 of 135

Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU

Z-1569-2017
Recall number
Z-1569-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
18 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030590C Exp Date 2017-10-30; 031852C Exp Date 2017-11-30;

Distribution pattern

US Distribution to LA and TX.

device · product 27 of 135

Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU

Z-1570-2017
Recall number
Z-1570-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
18 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033787D Exp Date 2018-03-30; 034306D Exp Date 2018-04-30;

Distribution pattern

US Distribution to LA and TX.

device · product 28 of 135

Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU

Z-1571-2017
Recall number
Z-1571-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
14 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037660E Exp Date 2018-04-30

Distribution pattern

US Distribution to LA and TX.

device · product 29 of 135

Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU

Z-1572-2017
Recall number
Z-1572-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
22 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

031017A Exp Date 2017-11-30; 032617A Exp Date 2018-03-30

Distribution pattern

US Distribution to LA and TX.

device · product 30 of 135

Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU

Z-1573-2017
Recall number
Z-1573-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
8 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038832B Exp Date 2018-06-30; 040636B Exp Date 2018-10-31

Distribution pattern

US Distribution to LA and TX.

device · product 31 of 135

Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU

Z-1574-2017
Recall number
Z-1574-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
704 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026598A Exp Date 2017-06-30; 028130A Exp Date 2017-07-30; 028918A Exp Date 2017-01-30; 029122A Exp Date 2017-09-30; 029906A Exp Date 2017-10-30; 031960A Exp Date 2018-01-30; 033019A Exp Date 2018-04-30;

Distribution pattern

US Distribution to LA and TX.

device · product 32 of 135

Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU

Z-1575-2017
Recall number
Z-1575-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
170 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037275C Exp Date 2018-08-03;

Distribution pattern

US Distribution to LA and TX.

device · product 33 of 135

Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU

Z-1576-2017
Recall number
Z-1576-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
248 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027338B Exp Date 2017-05-30; 027664B Exp Date 2017-06-30; 028391B Exp Date 2017-07-30; 028752B Exp Date 2017-07-30; 029416B Exp Date 2017-09-30; 030580B Exp Date 2017-10-30; 032134B Exp Date 2018-01-30;

Distribution pattern

US Distribution to LA and TX.

device · product 34 of 135

Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU

Z-1577-2017
Recall number
Z-1577-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
78 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

035171C Exp Date 2018-07-14;

Distribution pattern

US Distribution to LA and TX.

device · product 35 of 135

Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU

Z-1578-2017
Recall number
Z-1578-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
30 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

039908D Exp Date 2018-12-01;

Distribution pattern

US Distribution to LA and TX.

device · product 36 of 135

Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn

Z-1579-2017
Recall number
Z-1579-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
460 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027476B Exp Date 2017-08-12;

Distribution pattern

US Distribution to LA and TX.

device · product 37 of 135

Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn

Z-1580-2017
Recall number
Z-1580-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
117 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028316C Exp Date 2017-03-30; 028909C Exp Date 2017-03-30

Distribution pattern

US Distribution to LA and TX.

device · product 38 of 135

Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn

Z-1581-2017
Recall number
Z-1581-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
96 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027502C Exp Date 2017-08-17;

Distribution pattern

US Distribution to LA and TX.

device · product 39 of 135

Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn

Z-1582-2017
Recall number
Z-1582-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
120 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

024308 Exp Date 2017-04-06;

Distribution pattern

US Distribution to LA and TX.

device · product 40 of 135

Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn

Z-1583-2017
Recall number
Z-1583-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
86 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028252A Exp Date 2017-09-21;

Distribution pattern

US Distribution to LA and TX.

device · product 41 of 135

Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn

Z-1584-2017
Recall number
Z-1584-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
28 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026166A Exp Date 2017-07-06;

Distribution pattern

US Distribution to LA and TX.

device · product 42 of 135

Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn

Z-1585-2017
Recall number
Z-1585-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
36 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027617B Exp Date 2017-08-17;

Distribution pattern

US Distribution to LA and TX.

device · product 43 of 135

Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn

Z-1586-2017
Recall number
Z-1586-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
48 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028153 Exp Date 2017-09-16;

Distribution pattern

US Distribution to LA and TX.

device · product 44 of 135

Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper

Z-1587-2017
Recall number
Z-1587-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
10 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026200A Exp Date 2017-07-06;

Distribution pattern

US Distribution to LA and TX.

device · product 45 of 135

Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills

Z-1588-2017
Recall number
Z-1588-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
70 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027180B Exp Date 2017-07-27;

Distribution pattern

US Distribution to LA and TX.

device · product 46 of 135

Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills

Z-1589-2017
Recall number
Z-1589-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
344 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029709C Exp Date 2017-11-24; 029888C Exp Date 2017-12-07; 032207C Exp Date 2018-03-24; 033503C Exp Date 2018-05-11

Distribution pattern

US Distribution to LA and TX.

device · product 47 of 135

Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills

Z-1590-2017
Recall number
Z-1590-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
180 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037072D Exp Date 2018-03-30; 038802D Exp Date 2018-07-30;

Distribution pattern

US Distribution to LA and TX.

device · product 48 of 135

Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills

Z-1591-2017
Recall number
Z-1591-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
456 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

031066A Exp Date 2018-01-21; 031996A Exp Date 2018-03-02; 033021A Exp Date 2018-04-19

Distribution pattern

US Distribution to LA and TX.

device · product 49 of 135

Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills

Z-1592-2017
Recall number
Z-1592-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
590 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034267B Exp Date 2018-06-16; 036852B Exp Date 2018-07-26; 038768B Exp Date 2018-10-10;

Distribution pattern

US Distribution to LA and TX.

device · product 50 of 135

Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills

Z-1593-2017
Recall number
Z-1593-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
54 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033059B Exp Date 2018-04-21; 034067B Exp Date 2018-06-06;

Distribution pattern

US Distribution to LA and TX.

device · product 51 of 135

Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills

Z-1594-2017
Recall number
Z-1594-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
15 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

039418C Exp Date 2018-11-04; 040012C Exp Date 2018-12-05;

Distribution pattern

US Distribution to LA and TX.

device · product 52 of 135

Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills

Z-1595-2017
Recall number
Z-1595-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
12 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029195B Exp Date 2017-09-30;

Distribution pattern

US Distribution to LA and TX.

device · product 53 of 135

Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills

Z-1596-2017
Recall number
Z-1596-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
40 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

031013C Exp Date 2017-11-30; 031667C Exp Date 2017-12-30;

Distribution pattern

US Distribution to LA and TX.

device · product 54 of 135

Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills

Z-1597-2017
Recall number
Z-1597-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
45 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037607D Exp Date 2018-07-30; 039119D Exp Date 2018-07-30; 039575D Exp Date 2018-08-30;

Distribution pattern

US Distribution to LA and TX.

device · product 55 of 135

Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills

Z-1598-2017
Recall number
Z-1598-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
834 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027929B Exp Date 2017-08-30; 029240B Exp Date 2017-09-30; 030080B Exp Date 2017-10-30; 031818B Exp Date 2017-11-30;

Distribution pattern

US Distribution to LA and TX.

device · product 56 of 135

Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills

Z-1599-2017
Recall number
Z-1599-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
460 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038284E Exp Date 2018-09-20; 039282E Exp Date 2018-11-01;

Distribution pattern

US Distribution to LA and TX.

device · product 57 of 135

Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills

Z-1600-2017
Recall number
Z-1600-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
200 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033472B Exp Date 2018-05-09;

Distribution pattern

US Distribution to LA and TX.

device · product 58 of 135

Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills

Z-1601-2017
Recall number
Z-1601-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
290 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037810C Exp Date 2018-08-30; 039435C Exp Date 2018-11-07

Distribution pattern

US Distribution to LA and TX.

device · product 59 of 135

Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels

Z-1602-2017
Recall number
Z-1602-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
40 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033953B Exp Date 2018-06-02; 036773B Exp Date 2018-07-22

Distribution pattern

US Distribution to LA and TX.

device · product 60 of 135

Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels

Z-1603-2017
Recall number
Z-1603-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
40 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033953B Exp Date 2018-06-02; 036773B Exp Date 2018-07-22

Distribution pattern

US Distribution to LA and TX.

device · product 61 of 135

Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa

Z-1604-2017
Recall number
Z-1604-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
170 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030876A Exp Date 2018-01-14; 032509A Exp Date 2018-03-25

Distribution pattern

US Distribution to LA and TX.

device · product 62 of 135

Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa

Z-1605-2017
Recall number
Z-1605-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
276 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034265B Exp Date 2018-06-16; 037465B Exp Date 2018-08-17

Distribution pattern

US Distribution to LA and TX.

device · product 63 of 135

Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa

Z-1606-2017
Recall number
Z-1606-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
180 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034942B Exp Date 2018-07-08; 037820B Exp Date 2018-09-01

Distribution pattern

US Distribution to LA and TX.

device · product 64 of 135

Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa

Z-1607-2017
Recall number
Z-1607-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
12 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034595B Exp Date 2018-06-25;

Distribution pattern

US Distribution to LA and TX.

device · product 65 of 135

Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa

Z-1608-2017
Recall number
Z-1608-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
209 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027181A Exp Date 2017-03-30; 030175A Exp Date 2017-03-30; 030570A Exp Date 2017-11-30; 031809A Exp Date 2017-12-30; 032419A Exp Date 2018-03-25; 033639A Exp Date 2018-03-30;

Distribution pattern

US Distribution to LA and TX.

device · product 66 of 135

Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa

Z-1609-2017
Recall number
Z-1609-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
55 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037631B Exp Date 2018-07-30;

Distribution pattern

US Distribution to LA and TX.

device · product 67 of 135

Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa

Z-1610-2017
Recall number
Z-1610-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
90 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

032891A Exp Date 2018-04-13;

Distribution pattern

US Distribution to LA and TX.

device · product 68 of 135

Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa

Z-1611-2017
Recall number
Z-1611-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
100 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033846B Exp Date 2018-05-26;

Distribution pattern

US Distribution to LA and TX.

device · product 69 of 135

Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa

Z-1612-2017
Recall number
Z-1612-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
158 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038257C Exp Date 2018-09-16; 040017C Exp Date 2018-12-06;

Distribution pattern

US Distribution to LA and TX.

device · product 70 of 135

Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa

Z-1613-2017
Recall number
Z-1613-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
216 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030564A Exp Date 2017-11-30; 031034A Exp Date 2017-11-30; 0318321A Exp Date 2018-01-30; 033317A Exp Date 2018-03-30;

Distribution pattern

US Distribution to LA and TX.

device · product 71 of 135

Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa

Z-1614-2017
Recall number
Z-1614-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
70 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034869B Exp Date 2018-04-30;

Distribution pattern

US Distribution to LA and TX.

device · product 72 of 135

Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa

Z-1615-2017
Recall number
Z-1615-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
104 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

039125C Exp Date 2018-07-30; 040256C Exp Date 2018-09-30;

Distribution pattern

US Distribution to LA and TX.

device · product 73 of 135

Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa

Z-1616-2017
Recall number
Z-1616-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
430 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029078C Exp Date 2017-10-26; 030847C Exp Date 2018-01-12; 030847C Exp Date 2018-03-21;

Distribution pattern

US Distribution to LA and TX.

device · product 74 of 135

Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa

Z-1617-2017
Recall number
Z-1617-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
42 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034203A Exp Date 2017-11-30; 036670A Exp Date 2017-11-30;

Distribution pattern

US Distribution to LA and TX.

device · product 75 of 135

Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa

Z-1618-2017
Recall number
Z-1618-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
27 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037622B Exp Date 2018-08-23; 038777B Exp Date 2018-10-10;

Distribution pattern

US Distribution to LA and TX.

device · product 76 of 135

Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa

Z-1619-2017
Recall number
Z-1619-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
356 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027750A Exp Date 2017-08-24; 028676A Exp Date 2017-10-13; 029916A Exp Date 2017-12-08; 030661A Exp Date 2018-01-04; 034835A Exp Date 2018-07-11;

Distribution pattern

US Distribution to LA and TX.

device · product 77 of 135

Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa

Z-1620-2017
Recall number
Z-1620-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
120 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037945B Exp Date 2018-09-06; 039741B Exp Date 2018-11-21;

Distribution pattern

US Distribution to LA and TX.

device · product 78 of 135

Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa

Z-1621-2017
Recall number
Z-1621-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
284 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026566A Exp Date 2017-07-20; 030227A Exp Date 2017-12-23;

Distribution pattern

US Distribution to LA and TX.

device · product 79 of 135

Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa

Z-1622-2017
Recall number
Z-1622-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
148 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

032157B Exp Date 2018-03-11;

Distribution pattern

US Distribution to LA and TX.

device · product 80 of 135

Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa

Z-1623-2017
Recall number
Z-1623-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
150 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

033783C Exp Date 2017-08-30;

Distribution pattern

US Distribution to LA and TX.

device · product 81 of 135

Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa

Z-1624-2017
Recall number
Z-1624-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
280 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037471D Exp Date 2018-08-17; 038772D Exp Date 2018-10-10; 039620D Exp Date 2018-11-16;

Distribution pattern

US Distribution to LA and TX.

device · product 82 of 135

Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa

Z-1625-2017
Recall number
Z-1625-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
96 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030203A Exp Date 2017-12-22;

Distribution pattern

US Distribution to LA and TX.

device · product 83 of 135

Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa

Z-1626-2017
Recall number
Z-1626-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
189 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

032399B Exp Date 2018-03-22; 033495B Exp Date 2018-05-10;

Distribution pattern

US Distribution to LA and TX.

device · product 84 of 135

Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa

Z-1627-2017
Recall number
Z-1627-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
165 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034982C Exp Date 2018-07-09; 039451C Exp Date 2018-11-09;

Distribution pattern

US Distribution to LA and TX.

device · product 85 of 135

Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa

Z-1628-2017
Recall number
Z-1628-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
384 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028898B Exp Date 2017-10-19; 029882B Exp Date 2017-10-19; 031071B Exp Date 2018-01-25; 033617B Exp Date 2018-05-13;

Distribution pattern

US Distribution to LA and TX.

device · product 86 of 135

Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa

Z-1629-2017
Recall number
Z-1629-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
25 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

032109B Exp Date 2018-01-30;

Distribution pattern

US Distribution to LA and TX.

device · product 87 of 135

Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo

Z-1630-2017
Recall number
Z-1630-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
236 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026403B Exp Date 2017-07-13; 029909B Exp Date 2017-12-08; 031012B Exp Date 2018-01-18; 031963B Exp Date 2018-03-01;

Distribution pattern

US Distribution to LA and TX.

device · product 88 of 135

Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo

Z-1631-2017
Recall number
Z-1631-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
206 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034978C Exp Date 2018-07-09; 038090C Exp Date 2018-09-12; 039153C Exp Date 2018-10-26;

Distribution pattern

US Distribution to LA and TX.

device · product 89 of 135

Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa

Z-1632-2017
Recall number
Z-1632-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
46 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037469E Exp Date 2018-06-30;

Distribution pattern

US Distribution to LA and TX.

device · product 90 of 135

Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa

Z-1633-2017
Recall number
Z-1633-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
71 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029238B Exp Date 2017-03-30; 030816B Exp Date 2017-11-30; 034258B Exp Date 2018-04-30;

Distribution pattern

US Distribution to LA and TX.

device · product 91 of 135

Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa

Z-1634-2017
Recall number
Z-1634-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
25 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038092C Exp Date 2018-07-30; 039713C Exp Date 2018-08-30;

Distribution pattern

US Distribution to LA and TX.

device · product 92 of 135

Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland

Z-1635-2017
Recall number
Z-1635-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
92 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030226A Exp Date 2017-10-30; 032172A Exp Date 2018-02-28; 032696A Exp Date 2018-03-30; 033176A Exp Date 2018-04-26;

Distribution pattern

US Distribution to LA and TX.

device · product 93 of 135

Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland

Z-1636-2017
Recall number
Z-1636-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
92 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030226A Exp Date 2017-10-30; 032172A Exp Date 2018-02-28; 032696A Exp Date 2018-03-30; 033176A Exp Date 2018-04-26;

Distribution pattern

US Distribution to LA and TX.

device · product 94 of 135

Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa

Z-1637-2017
Recall number
Z-1637-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
240 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

031463A Exp Date 2017-12-30; 032411A Exp Date 2018-02-28; 032871A Exp Date 2018-03-30; 033654A Exp Date 2018-03-30;

Distribution pattern

US Distribution to LA and TX.

device · product 95 of 135

Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn

Z-1638-2017
Recall number
Z-1638-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
5,000 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028131A Exp Date 2017-09-16; 028606A Exp Date 2017-10-13; 029244A Exp Date 2017-11-02; 029917A Exp Date 2017-12-08; 030686A Exp Date 2018-01-04; 031323A Exp Date 2018-02-01; 031824A Exp Date 2018-02-24; 032567A Exp Date 2018-03-31; 033054A Exp Date 2018-04-21; 033680A Exp Date 2018-05-19;

Distribution pattern

US Distribution to LA and TX.

device · product 96 of 135

Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn

Z-1639-2017
Recall number
Z-1639-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
3,000 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034435B Exp Date 2018-6-21; 037051B Exp Date 2018-6-21; 037462B Exp Date 2018-07-29; 038293B Exp Date 2018-08-17; 038779B Exp Date 2018-09-21; 039465B Exp Date 2018-10-10; 040093B Exp Date 2018-11-09;

Distribution pattern

US Distribution to LA and TX.

device · product 97 of 135

Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn

Z-1640-2017
Recall number
Z-1640-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
840 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038098D Exp Date 2018-9-12; 039573D Exp Date 2018-9-12

Distribution pattern

US Distribution to LA and TX.

device · product 98 of 135

Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn

Z-1641-2017
Recall number
Z-1641-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
690 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028113B Exp Date 2017-09-15; 030842B Exp Date 2018-01-11; 031792B Exp Date 2018-01-30

Distribution pattern

US Distribution to LA and TX.

device · product 99 of 135

Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn

Z-1642-2017
Recall number
Z-1642-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
230 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034222S Exp Date 2018-06-14

Distribution pattern

US Distribution to LA and TX.

device · product 100 of 135

Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn

Z-1643-2017
Recall number
Z-1643-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
430 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037438D Exp Date 2018-8-15; 038495D Exp Date 2018-9-29

Distribution pattern

US Distribution to LA and TX.

device · product 101 of 135

Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn

Z-1644-2017
Recall number
Z-1644-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
2016 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027525B Exp Date 2017-08-14; 028915B Exp Date 2017-10-19; 030195B Exp Date 2017-12-21; 031255B Exp Date 2018-01-29; 032688B Exp Date 2017-09-30; 033330B Exp Date 2018-05-03

Distribution pattern

US Distribution to LA and TX.

device · product 102 of 135

Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn

Z-1645-2017
Recall number
Z-1645-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
1224 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034494C Exp Date 2018-06-25; 037642C Exp Date 2018-08-25; 038956C Exp Date 2018-10-19; 040142C Exp Date 2018-12-09

Distribution pattern

US Distribution to LA and TX.

device · product 103 of 135

Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn

Z-1646-2017
Recall number
Z-1646-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
274 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029922D Exp Date 2017-10-30; 031037D Exp Date 2017-12-30; 032865D Exp Date 2018-3-30

Distribution pattern

US Distribution to LA and TX.

device · product 104 of 135

Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn

Z-1647-2017
Recall number
Z-1647-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
228 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034408E Exp Date 2018-04-30; 038488E Exp Date 2018-06-30; 039730E Exp Date 2018-08-30

Distribution pattern

US Distribution to LA and TX.

device · product 105 of 135

Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn

Z-1648-2017
Recall number
Z-1648-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
1056 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

027522B Exp Date 2017-03-30; 030020B Exp Date 2017-10-30; 031641B Exp Date 2017-12-30; 033142B Exp Date 2017-12-30; 034112B Exp Date 2018-04-30

Distribution pattern

US Distribution to LA and TX.

device · product 106 of 135

Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn

Z-1649-2017
Recall number
Z-1649-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
436 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037464C Exp Date 2018-04-30; 038804C Exp Date 2018-04-30; 040546C Exp Date 2018-10-31

Distribution pattern

US Distribution to LA and TX.

device · product 107 of 135

Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn

Z-1650-2017
Recall number
Z-1650-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
372 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

031038D Exp Date 2018-01-19; 032139D Exp Date 2018-03-09; 034081D Exp Date 2018-06-08

Distribution pattern

US Distribution to LA and TX.

device · product 108 of 135

Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn

Z-1651-2017
Recall number
Z-1651-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
164 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038155E Exp Date 2018-09-15; 039572E Exp Date 2018-11-12

Distribution pattern

US Distribution to LA and TX.

device · product 109 of 135

Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn

Z-1652-2017
Recall number
Z-1652-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
496 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029881B Exp Date 2017-12-04; 030864B Exp Date 2018-01-13; 032446B Exp Date 2018-3-25; 033940B Exp Date 2018-06-02

Distribution pattern

US Distribution to LA and TX.

device · product 110 of 135

Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn

Z-1653-2017
Recall number
Z-1653-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
382 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029920B Exp Date 2017-12-09; 030885B Exp Date 2018-01-14; 033055B Exp Date 2018-04-21

Distribution pattern

US Distribution to LA and TX.

device · product 111 of 135

Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn

Z-1654-2017
Recall number
Z-1654-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
208 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037610C Exp Date 2018-08-23; 038494C Exp Date 2018-09-28; 040237C Exp Date 2018-12-09

Distribution pattern

US Distribution to LA and TX.

device · product 112 of 135

Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn

Z-1655-2017
Recall number
Z-1655-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
288 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028912A Exp Date 2017-10-16; 030725A Exp Date 2018-01-08; 031994A Exp Date 2018-03-02; 033625A Exp Date 2018-02-20

Distribution pattern

US Distribution to LA and TX.

device · product 113 of 135

Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn

Z-1656-2017
Recall number
Z-1656-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
249 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

035084B Exp Date 2018-07-13; 038325B Exp Date 2018-09-22; 039576B Exp Date 2018-11-12

Distribution pattern

US Distribution to LA and TX.

device · product 114 of 135

Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn

Z-1657-2017
Recall number
Z-1657-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
216 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026440A Exp Date 2017-07-16; 030021A Exp Date 2017-12-11; 030186A Exp Date 2017-12-21; 031464A Exp Date 2018-02-15; 032390A Exp Date 2018-03-22; 033782A Exp Date 2018-05-20

Distribution pattern

US Distribution to LA and TX.

device · product 115 of 135

Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn

Z-1658-2017
Recall number
Z-1658-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
92 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

036643B Exp Date 2018-07-19; 038943B Exp Date 2018-10-17

Distribution pattern

US Distribution to LA and TX.

device · product 116 of 135

Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn

Z-1659-2017
Recall number
Z-1659-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
148 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

029296B Exp Date 2017-11-04; 030567B Exp Date 2017-12-29; 031350B Exp Date 2018-02-03; 033935B Exp Date 2017-06-30

Distribution pattern

US Distribution to LA and TX.

device · product 117 of 135

Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn

Z-1660-2017
Recall number
Z-1660-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
56 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037420C Exp Date 2018-08-12; 039995C Exp Date 2018-12-02

Distribution pattern

US Distribution to LA and TX.

device · product 118 of 135

Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn

Z-1661-2017
Recall number
Z-1661-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
450 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030228A Exp Date 2017-12-23; 031467A Exp Date 2018-02-09; 032767A Exp Date 2018-04-07

Distribution pattern

US Distribution to LA and TX.

device · product 119 of 135

Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn

Z-1662-2017
Recall number
Z-1662-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
350 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

035042B Exp Date 2018-07-12; 038457B Exp Date 2018-09-23; 039618B Exp Date 2018-11-15

Distribution pattern

US Distribution to LA and TX.

device · product 120 of 135

Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn

Z-1663-2017
Recall number
Z-1663-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
110 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

031160C Exp Date 2018-01-22; 032881C Exp Date 2018-04-12

Distribution pattern

US Distribution to LA and TX.

device · product 121 of 135

Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn

Z-1664-2017
Recall number
Z-1664-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
162 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

034404D Exp Date 2018-06-20; 037483D Exp Date 2018-08-18; 039644D Exp Date 2018-11-16

Distribution pattern

US Distribution to LA and TX.

device · product 122 of 135

Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn

Z-1665-2017
Recall number
Z-1665-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
306 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030684A Exp Date 2018-01-04; 032158A Exp Date 2018-03-11; 033365A Exp Date 2018-05-05; 034402A Exp Date 2018-06-20

Distribution pattern

US Distribution to LA and TX.

device · product 123 of 135

Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn

Z-1666-2017
Recall number
Z-1666-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
118 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037054B Exp Date 2018-07-29; 039606B Exp Date 2018-11-15

Distribution pattern

US Distribution to LA and TX.

device · product 124 of 135

Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper

Z-1667-2017
Recall number
Z-1667-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
126 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026395B Exp Date 2017-07-13; 027756B Exp Date 2017-08-24; 030702B Exp Date 2018-01-05; 034442B Exp Date 2018-06-21

Distribution pattern

US Distribution to LA and TX.

device · product 125 of 135

Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper

Z-1668-2017
Recall number
Z-1668-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
24 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037441C Exp Date 2018-08-15

Distribution pattern

US Distribution to LA and TX.

device · product 126 of 135

Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper

Z-1669-2017
Recall number
Z-1669-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
32 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038465D Exp Date 2018-08-31

Distribution pattern

US Distribution to LA and TX.

device · product 127 of 135

Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper

Z-1670-2017
Recall number
Z-1670-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
32 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

038465D Exp Date 2018-08-31

Distribution pattern

US Distribution to LA and TX.

device · product 128 of 135

Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini

Z-1671-2017
Recall number
Z-1671-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
454 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028544D Exp Date 2017-10-06; 031310D Exp Date 2018-01-29; 031515D Exp Date 2018-03-29; 032531D Exp Date 2018-03-29; 034656D Exp Date 2018-06-28

Distribution pattern

US Distribution to LA and TX.

device · product 129 of 135

Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini

Z-1672-2017
Recall number
Z-1672-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
212 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037619E Exp Date 2018-08-23; 038962E Exp Date 2018-10-20; 039792E Exp Date 2018-11-29

Distribution pattern

US Distribution to LA and TX.

device · product 130 of 135

Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa

Z-1673-2017
Recall number
Z-1673-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
30 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026545A Exp Date 2017-03-30

Distribution pattern

US Distribution to LA and TX.

device · product 131 of 135

Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills

Z-1674-2017
Recall number
Z-1674-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
210 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

030102A Exp Date 2017-12-17

Distribution pattern

US Distribution to LA and TX.

device · product 132 of 135

Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa

Z-1675-2017
Recall number
Z-1675-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
90 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

028437B Exp Date 2017-08-30; 030579B Exp Date 2017-11-30

Distribution pattern

US Distribution to LA and TX.

device · product 133 of 135

Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU

Z-1676-2017
Recall number
Z-1676-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
30 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

032677F Exp Date 2017-12-30

Distribution pattern

US Distribution to LA and TX.

device · product 134 of 135

Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis

Z-1677-2017
Recall number
Z-1677-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
670 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

026385D Exp Date 2017-07-13; 028105D Exp Date 2017-09-14; 029774D Exp Date 2017-12-04; 031980D Exp Date 2018-03-02; 033476D Exp Date 2018-05-10

Distribution pattern

US Distribution to LA and TX.

device · product 135 of 135

Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU

Z-1678-2017
Recall number
Z-1678-2017
Initiated
January 09, 2017
Classification
Class II
Status
Terminated
Quantity
660 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breaking the sterile field

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Code information

037658B Exp Date 2018-08-26; 038468B Exp Date 2018-09-26; 040771B Exp Date 2018-12-28

Distribution pattern

US Distribution to LA and TX.