Ethicon recalls PROLE:NE Suture 4-36" 4-0 Blue (D5988) due to packaging perforation risk. Perforated packaging could cause soft tissue injury or patient infection if sterility is breached.
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.
Ethicon is recalling PROLENE Suture 4-36" 4-0 Blue (D5988) because the packaging may perforate, risking soft tissue injury to healthcare workers or patient infections if sterility is compromised.
The suture packaging design can perforate, which may lead to soft tissue injury for healthcare workers handling it or patient infections if the packaging breach goes unnoticed and sterility is compromised.
Healthcare professionals and patients using the recalled suture product are at risk if the packaging perforates, potentially causing injury or infection.
Check for the product code D5988 on the packaging. The suture is 4-36" (90cm) 4-0 blue, sold under specific model numbers including KEB377, KEH280, KGP662, KMJ048, KPP500, LCH042, LHP301, LJE786, LPB869, MAH170, MCH330, MCQ992.
Inspect the suture packaging for any holes or tears that could indicate perforation.
The packaging design can perforate, which may cause soft tissue injury to healthcare workers or patient infections if sterility is compromised.
Look for the product code D5988 on the packaging. The suture is 4-36" (90cm) 4-0 blue, sold under specific model numbers including KEB377, KEH280, KGP662, KMJ048, KPP500, LCH042, LHP301, LJE786, LPB869, MAH170, MCH330, MCQ992.
Check the packaging for perforations. If you find perforations, stop using it and contact Ethicon for guidance.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2450-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2450-2018 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
