Ethicon recalls PROLENE Suture Blue 48" 4-0 D/A with potential packaging perforation causing soft tissue injury or infection. Affected products have specific codes listed in the recall notice.
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 certain PROLENE Suture Blue 48" 4-0 D/A products due to a packaging design flaw that could cause the package to perforate. This poses a risk of soft tissue injury to healthcare workers or patient infections if sterility is compromised.
The packaging design issue can cause the package to perforate, potentially leading to soft tissue injury for healthcare workers or patient infections if the breach goes unnoticed and sterility is compromised.
Healthcare professionals and patients using the recalled suture products are at risk. The risk is highest for those handling the product without proper checks for packaging integrity.
Check for the product codes listed: D9746, KDH782, KEH344, KEJ158, KGJ668, KGQ354, KJE929, KJH424, KKJ658, LAB267, LCH376, LCH571, LEB803, LGB860, LKR893, LPJ096, LPP510, MCJ449, MCQ993.
Identify if your suture has one of the listed codes: D9746, KDH782, KEH344, KEJ158, KGJ668, KGQ354, KJE929, KJH424, KKJ658, LAB267, LCH376, LCH571, LEB803, LGB860, LKR893, LPJ096, LPP510, MCJ449, MCQ993.
The packaging design can cause the package to perforate, potentially leading to soft tissue injury for healthcare workers or patient infections if sterility is compromised.
Check for the product codes listed: D9746, KDH782, KEH344, KEJ158, KGJ668, KGQ354, KJE929, KJH424, KKJ658, LAB267, LCH376, LCH571, LEB803, LGB860, LKR893, LPJ096, LPP510, MCJ449, MCQ993.
No, but you should check if your suture has one of the listed codes and take appropriate action if it does.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2461-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2461-2018 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.
