Ethicon recalls PROLENE Suture Monobundle (BV1755 Taper Point 3/8C, D10031) due to packaging perforation risk. Perforated packaging may 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 specific PROLENE sutures because their packaging can tear easily, potentially causing injuries to healthcare workers or infections in patients if the tear isn't noticed.
The suture packaging has a design flaw that can cause it to tear. If the packaging tears, it might lead to soft tissue injuries for healthcare workers or patient infections if the tear isn't noticed and sterility is compromised.
Healthcare professionals and patients using the recalled suture products are at risk. The risk is low because the packaging perforation is unlikely to occur in normal use and requires specific handling conditions.
Check for the product code BV1755 Taper Point 3/8C, D10031 on the packaging. The recalled items were sold under specific model numbers: KDJ805, KDP827, LBB354, MAP602.
Look for the product code BV1755 Taper Point 3/8C, D10031 on the packaging.
The packaging can tear easily, which might cause soft tissue injuries to healthcare workers or patient infections if sterility is breached.
Check the packaging for the product code BV1755 Taper Point 3/8C, D10031. If you have it, contact Ethicon for more information.
The recall states the risk is low because the packaging perforation is unlikely to occur in normal use and requires specific handling conditions.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2448-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2448-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
