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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80306

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

Open FDA event record

Event summary

Timeline bucket
May 07, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ethicon, Inc.

Dossier provenance

Source snapshots represented here

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

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

How coverage and grouping work

Complete imported group

Every recalled product in this event

19 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 19

PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

Z-2448-2018
Recall number
Z-2448-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
1752

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KDJ805 KDP827 LBB354 MAP602

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 2 of 19

PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

Z-2449-2018
Recall number
Z-2449-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
1728

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KGJ667 KJJ690 KMH714 KPP499 LBJ528 LCJ143 LPJ095 MDH288

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 3 of 19

PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

Z-2450-2018
Recall number
Z-2450-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
4452

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KEB377 KEH280 KGP662 KMJ048 KPP500 LCH042 LHP301 LJE786 LPB869 MAH170 MCH330 MCQ992

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 4 of 19

PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416

Z-2451-2018
Recall number
Z-2451-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
3024

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KEH479 KHH259 KLH655 KMH715 LCH548 LHP422 LJJ896 MAR884

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 5 of 19

PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

Z-2452-2018
Recall number
Z-2452-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
2844

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KDH853 KKH769 KLQ193 KPH698 LCH183 LCH570 LGB761 LJB020 LJH536 MCJ369 MCJ447

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 6 of 19

PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

Z-2453-2018
Recall number
Z-2453-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
15180

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KDH099 KDJ422 KDJ564 KEB962 KEE491 KEE541 KKH770 KKJ554 KKJ555 KKJ688 KMB434 KMP958 KPH281 KPP708 KPP709 LBJ626 LCH208 LDH331 LEP836 LGB696 LGP653 LHB978 LHH617 LJE597 LKH051 LMH352 LPJ187 LPJ672 LPP509 MCJ330 MCJ448 MDH289 MCQ533

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 7 of 19

PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879

Z-2454-2018
Recall number
Z-2454-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
588

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KEB378 KKJ784 MCP374

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 8 of 19

PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

Z-2455-2018
Recall number
Z-2455-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
432

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

LLH858

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 9 of 19

PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647

Z-2456-2018
Recall number
Z-2456-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
300

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

LEH169 MCH333

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 10 of 19

PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

Z-2457-2018
Recall number
Z-2457-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
552

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

LCB888 LCH204

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 11 of 19

PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

Z-2458-2018
Recall number
Z-2458-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
456

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

LDP667 LPH861

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 12 of 19

PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

Z-2459-2018
Recall number
Z-2459-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
1020

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KKJ659 LAH044 LEH699 MCH331 MDH290 MCQ536

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 13 of 19

PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662

Z-2460-2018
Recall number
Z-2460-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
48

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

MBJ454

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 14 of 19

PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

Z-2461-2018
Recall number
Z-2461-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
4440

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KDH782 KEH344 KEJ158 KGJ668 KGQ354 KJE929 KJH424 KKJ658 LAB267 LCH376 LCH571 LEB803 LGB860 LKR893 LPJ096 LPP510 MCJ449 MCQ993

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 15 of 19

PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

Z-2462-2018
Recall number
Z-2462-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
4968

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KDQ180 KJH311 KKH758 KMP871 KPH811 LAH127 LAH648 LDP694 LHB945 LJE966 LMJ318 LMR835 MAH349 MBE216 MCQ994 MCQ537 MCQ538

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 16 of 19

PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

Z-2463-2018
Recall number
Z-2463-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
276

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KJQ124

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 17 of 19

PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

Z-2464-2018
Recall number
Z-2464-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
372

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

LCJ948 MCQ529

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 18 of 19

PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027

Z-2465-2018
Recall number
Z-2465-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
144

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KJQ311 KKE670

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

device · product 19 of 19

PRONOVA SUTURE BLUE 122CM M1.5, D10189

Z-2466-2018
Recall number
Z-2466-2018
Initiated
May 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
516

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue
Labeling or packaging reason.labeling_packaging · v1.0.0
packaging design issue
Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Code information

KDQ147 KEJ159 KGH788

Distribution pattern

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.