Ethicon recalls PROLENE Suture 30" 6-0 Blue (D8647) due to packaging perforation risk causing soft tissue injury or infection. Learn if you have the product and what to do.
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 30" 6-0 Blue (D8647) because the packaging may perforate, potentially causing injury to healthcare workers or infections if not noticed.
The suture packaging design can perforate, which may lead to soft tissue injury for healthcare workers or patient infections if the breach isn't detected during use.
Healthcare professionals and patients using this suture product during procedures. Those handling the product without checking for packaging perforations are at higher risk.
Check for the product code D8647 on the packaging. This suture is 30 inches (75 cm) long, 6-0 blue color, and sold under the brand name PROLENE.
Inspect the suture packaging for any holes or tears that could indicate perforation.
The recall states the packaging may perforate, but the product itself is safe if the packaging remains intact. However, users should check for perforations before use.
Look for the product code D8647 on the packaging, which identifies this specific suture as recalled.
Discard the product immediately and contact Ethicon for further instructions.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2456-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2456-2018 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.
