Covidien recalls specific Surgilon nylon sutures due to gamma sterilization exceeding approved levels, potentially weakening sutures over time and causing wound dehiscence or severe bleeding.
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
Covidien is recalling specific lots of Surgilon braided nylon sutures because they were sterilized with gamma radiation levels higher than approved. This could weaken the sutures over time, increasing the risk of wounds reopening or severe bleeding during surgery.
The sutures were sterilized with gamma radiation doses exceeding the approved range. This extra radiation can gradually reduce the suture strength over time, potentially causing wounds to reopen (dehiscence) or leading to significant blood loss during critical surgical moments.
Surgionists and medical professionals who use these specific Surgilon sutures are most at risk, as weakened sutures could lead to serious complications during procedures.
Check for the specific model numbers: 88861919-31 (4-0), 88861919-41 (3-0), 88861919-51 (2-0), and 88861919-71 (1) with the listed lot codes. These sutures were sold with specific UDI-DI numbers and lot identifiers.
Identify the model number and lot codes on the suture packaging to confirm if it's in the recalled range.
No, only specific model numbers and lot codes with the listed UDI-DI and lot identifiers are affected.
The recall record does not specify a remedy, so contact the manufacturer for guidance on safe handling or disposal.
Yes, weakened sutures could lead to wound dehiscence or severe bleeding during surgery.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0844-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0844-2024 from Covidien. 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.
