Ethicon recalls PRONOVA Suture Blue 122cm M1.5 (D10189) due to packaging perforation risk causing soft tissue injury or infection. Affected items have specific codes.
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 certain PRONOVA Suture Blue 122cm M1.5 products because the packaging can perforate, potentially causing injury to healthcare workers or infections if not noticed.
The packaging design issue can cause the package to perforate, which may lead to soft tissue injury for healthcare workers handling the product or patient infections if sterility is breached and unnoticed.
Healthcare professionals and patients using the recalled suture products are most at risk due to potential packaging perforation.
Check for the product code D10189 on the packaging. Affected items include PRONOVA Suture Blue 122cm M1.5 with specific codes KDQ147, KEJ159, KGH788.
Look for the product code D10189 on the packaging of the suture product.
The packaging design issue can cause the package to perforate, potentially causing soft tissue injury to healthcare workers or patient infections if sterility is breached and unnoticed.
Check the product code on the packaging. If it matches D10189 with codes KDQ147, KEJ159, or KGH788, stop using it and contact Ethicon for guidance.
The recall states the packaging perforation could cause soft tissue injury or infection, but the remedy does not specify immediate stop-use or return.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2466-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2466-2018 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.
