Ethicon recalls PROLENE Suture Blue 18" 7-0 D/A BV-1 packaging that may perforate, risking soft tissue injury or infection if not handled properly.
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 18" 7-0 D/A BV-1 packaging that could perforate, potentially causing injury to healthcare workers or infections if the packaging breach goes unnoticed.
The packaging design issue can cause the package to perforate. If a healthcare professional or patient handles the product without noticing the perforation, it could lead to soft tissue injury or infection due to a breach in sterility.
Healthcare professionals and patients using this suture product may be at risk if the packaging perforates, potentially leading to injury or infection.
Check for the product code PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 or LCJ948 MCQ529 on the packaging.
Inspect the packaging for any holes or tears that could indicate a perforation.
The recall states the packaging may perforate, risking injury or infection if not handled properly. Do not use if you find perforations.
Check the packaging for perforations. If you find any, stop using it and contact Ethicon for guidance.
Look for the product code PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 or LCJ948 MCQ529 on the packaging.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2464-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2464-2018 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.
