Ethicon recalls specific PRONOVA Suture Blue Monopoly products due to packaging perforation risk, potentially causing soft tissue injury or infection if not handled properly.
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 Monopoly products because their packaging may perforate, risking soft tissue injury to healthcare workers or patient infections. This is a safety issue that requires immediate attention to prevent harm.
The packaging design issue can cause the product to perforate, which may lead to soft tissue injury for healthcare workers or patient infections if the breach goes unnoticed.
Healthcare professionals and patients using the recalled suture products are most at risk. The specific product codes D10027 and KJQ311 KKE670 are affected.
Check for product codes D10027 or KJQ311 KKE670 on the packaging. The product is a blue mono-poly suture with a taper point and 1/2C size.
Look for the product codes D10027 or KJQ311 KKE670 on the packaging.
The packaging design can cause the product to perforate, potentially leading to soft tissue injury for healthcare workers or patient infections if the breach goes unnoticed.
Check for product codes D10027 or KJQ311 KKE670 on the packaging. The product is a blue mono-poly suture with a taper point and 1/2C size.
The recall record does not specify a remedy, so contact Ethicon directly for guidance.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2465-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2465-2018 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.
