Ethicon recalls PROLENE Suture 30" (75cm) 4-0 Blue D7748 due to packaging perforation risk causing soft tissue injury or infection. Affected units include specific model 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 PROLENE Suture 30" (75cm) 4-0 Blue products with model codes D7748, KDH853, KKH769, KLQ193, KPH698, LCH183, LCH570, LGB761, LJH536, MCJ369, MCJ447. The packaging may perforate, risking 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 the recalled suture products. Those handling the product without proper sterility checks are at higher risk.
Check for the product code D7748 or model numbers KDH853, KKH769, KLQ193, KPH698, LCH183, LCH570, LGB761, LJH536, MCJ369, MCJ447 on the packaging. These are specific model codes for the recalled suture products.
Inspect the suture packaging for perforations before use. If the packaging is damaged, do not use the product.
The product may have packaging perforations that could cause injury or infection if not handled properly. Do not use if packaging is damaged.
Look for the model codes D7748 or KDH853, KKH769, KLQ193, KPH698, LCH183, LCH570, LGB761, LJH536, MCJ369, MCJ447 on the packaging.
Inspect the packaging for perforations. If damaged, do not use the product. Contact Ethicon for further guidance if needed.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2452-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2452-2018 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.
