Ethicon recalls PROLENE Suture Monobond Blue BV1755 Taperpoint 3/8C, D9995 due to packaging perforation risk causing soft tissue injury or infection.
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 a specific blue suture product because its packaging can tear easily, potentially causing injuries to healthcare workers or infections in patients if the tear isn't noticed.
The suture's packaging design can tear, which may lead to soft tissue injuries for healthcare workers or patient infections if the tear isn't detected before use.
Healthcare professionals and patients using this suture product are at risk if the packaging tears during handling. The risk is highest for those handling the product without checking for packaging integrity.
Check for the product code BV1755 Taperpoint 3/8C, D9995 or KJQ124 on the packaging. This suture is blue and made by Ethicon.
Inspect the packaging for tears or punctures before use.
Yes, if the packaging tears, it could cause soft tissue injury to healthcare workers or patient infections.
Look for the product code BV1755 Taperpoint 3/8C, D9995 or KJQ124 on the blue packaging.
The recall does not provide a fix; users must check packaging for tears before use.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2463-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2463-2018 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.