Ethicon recalls PROLE: 36" 3-0 BLU suture 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 PROLENE Suture 36" 3-0 BLU (D9844) because its packaging can perforate, potentially causing injury to healthcare workers or infections in patients if the breach isn't noticed.
The suture's packaging design can perforate, creating a breach in sterility. If unnoticed, this breach could lead to soft tissue injury for healthcare workers or patient infections.
Healthcare professionals and patients using this suture product are at risk. Healthcare workers handling the product are most vulnerable to soft tissue injury.
Check for the product code D9844 on the packaging. This suture is sold under specific codes including KDQ180, KJH311, KKH758, and others listed in the recall notice.
Inspect the packaging for any signs of perforation before use. If perforated, do not use the product.
The recall is for packaging perforation risk, not the suture itself. Proper use does not cause the issue.
Look for the product code D9844 on the packaging, which includes specific codes like KDQ180, KJH311, KKH758, and others listed in the recall notice.
No immediate stop is required, but check packaging for perforation before use. If perforated, do not use.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2462-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2462-2018 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.
