Ethicon recalls PROLENE Suture Blue 4X18"5/0 DA RB-2 +PLG (D7879) due to packaging perforation risk. A perforated package 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 Blue 4X18"5/0 DA RB-2 +PLG (D7879) because the packaging may perforate, risking soft tissue 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 breach goes unnoticed and sterility is compromised.
Healthcare professionals and patients using this suture product are at risk if the packaging perforates. The risk is highest for those handling the product without checking for packaging integrity.
Check for the product code D7879 on the packaging. This suture is sold under the brand name PROLENE Suture Blue 4X18"5/0 DA RB-2 +PLG.
Inspect the packaging for perforations before use. If perforated, do not use the product.
Yes, if the packaging is intact and not perforated. The recall is only for products with potential packaging perforation.
Discard the product immediately and contact Ethicon for further instructions.
Look for the product code D7879 on the packaging. This suture is sold under the brand name PROLENE Suture Blue 4X18"5/0 DA RB-2 +PLG.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2454-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2454-2018 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.
