Medium RiskFDA Device

Ethicon, Inc.: 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.

Agency Publication Date: July 17, 2018

Affected Products

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

KDJ805 KDP827 LBB354 MAP602

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

KGJ667 KJJ690 KMH714 KPP499 LBJ528 LCJ143 LPJ095 MDH288

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

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

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

KEH479 KHH259 KLH655 KMH715 LCH548 LHP422 LJJ896 MAR884

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

KDH853 KKH769 KLQ193 KPH698 LCH183 LCH570 LGB761 LJB020 LJH536 MCJ369 MCJ447

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

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

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

KEB378 KKJ784 MCP374

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

LLH858

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

LEH169 MCH333

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

LCB888 LCH204

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

LDP667 LPH861

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

KKJ659 LAH044 LEH699 MCH331 MDH290 MCQ536

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

MBJ454

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

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

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

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

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

KJQ124

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

LCJ948 MCQ529

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

KJQ311 KKE670

Product: PRONOVA SUTURE BLUE 122CM M1.5, D10189

KDQ147 KEJ159 KGH788

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80306

Status: Resolved

Manufacturer: Ethicon, Inc.

Manufactured In: United States

Units Affected: 19 products (1752; 1728; 4452; 3024; 2844; 15180; 588; 432; 300; 552; 456; 1020; 48; 4440; 4968; 276; 372; 144; 516)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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