Ethicon recalls PROLE:NE Suture 4" 8-0 Blue (D9662) 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" 8-0 Blue (D9662) because the packaging may perforate, risking soft tissue injury to healthcare workers or patient infections if sterility is compromised.
The suture's packaging design can cause holes, which might lead to contamination. If a healthcare worker or patient is exposed to the perforated packaging, it could cause injury or infection.
Healthcare professionals and patients using this suture product are at risk. The risk is highest for those handling the product without checking for packaging integrity.
Check for the product code D9662 on the packaging. This suture is 4" (10cm) 8-0 blue and sold under the model MBJ454.
Inspect the packaging for perforations before use. If the package is damaged, do not use the suture.
The product may have packaging perforations that could cause injury or infection. Always check for damage before use.
Look for the product code D9662 on the packaging. This suture is 4" (10cm) 8-0 blue and sold under model MBJ454.
Inspect the packaging for perforations. If damaged, do not use the suture. Contact Ethicon for further guidance.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2460-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2460-2018 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.
