Ethicon recalls PROLENE Suture Blue 4x90cm products due to packaging that may perforate, risking soft tissue injury or infection for healthcare workers or patients.
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 Blue 4x90cm products because their packaging could tear, potentially causing soft tissue injuries to healthcare workers or infections for patients.
The suture packaging design can perforate, which may lead to soft tissue injuries for healthcare workers handling the product or infections for patients if the tear goes unnoticed.
Healthcare professionals and patients using the recalled suture products are at risk of soft tissue injury or infection if the packaging tears.
Check for the product code D5981 or the specific suture names listed: PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P. These products were sold in the U.S. and Canada.
Look for the product code D5981 or the listed suture names to confirm if your item is recalled.
The packaging design can perforate, potentially causing soft tissue injuries to healthcare workers or infections for patients if the tear goes unnoticed.
The recall record does not specify a remedy or fix.
Check for the product code D5981 or the specific suture names listed: PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2449-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2449-2018 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.
