Ethicon recalls PROLENE Suture 4-36" 3-0 Blue (D6416) due to packaging perforation risk. Perforated packaging could 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 PROLENE Suture 4-36" (90CM) 3-0 Blue (D6416) because the packaging may perforate, risking soft tissue injury to healthcare workers or patient infections if sterility is compromised.
The suture packaging design can perforate, potentially causing soft tissue injury to healthcare workers or patient infections if the packaging breach goes unnoticed and sterility is compromised.
Healthcare professionals and patients using this suture product during procedures. Those handling the product without proper sterility checks are at higher risk.
Check for the product code D6416 on the packaging. The suture is 3-0 blue, 4-36" (90CM) in length. It was sold under specific model numbers including KEH479, KHH259, KLH655, KMH715, LCH548, LHP422, LJJ896, MAR884.
Inspect the suture packaging for any holes or tears that could indicate perforation.
The recall is for packaging perforation risk, not the suture itself. Proper use with intact packaging should not cause injury.
Look for the product code D6416 on the packaging. The suture is 3-0 blue, 4-36" (90CM) in length and sold under specific model numbers including KEH479, KHH259, KLH655, KMH715, LCH548, LHP422, LJJ896, MAR884.
The recall does not require immediate stop use. Check packaging for perforation 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-2451-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2451-2018 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.
