Covidien recalls specific lots of Sofsilk Braided Silk sutures due to gamma sterilization exceeding approved levels, which may weaken sutures over time and cause 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 Sofsilk Braided Silk sutures because they were sterilized with gamma radiation levels higher than approved. This could weaken the sutures over time, potentially causing wounds to reopen or severe bleeding.
The sutures were sterilized with gamma radiation doses exceeding the approved range. This extra radiation can weaken the sutures over time, increasing the risk of wounds reopening (dehiscence) or severe bleeding during or after surgery.
Healthcare professionals and surgical teams who use the recalled Sofsilk Braided Silk sutures for procedures. Patients at risk include those undergoing surgery with these sutures.
Check for the specific model numbers and lot numbers listed in the recall notice. The affected sutures include Sofsilk Braided Silk models like CS-211, GS-831, S-176, and others with the corresponding lot numbers and UDI-DI codes.
Identify the model number and lot number on the suture packaging to determine if it is in the recalled list.
Reach out to Covidien directly for assistance with the recall process if you have the recalled sutures.
The recall indicates that specific lots of these sutures were sterilized with gamma radiation levels exceeding approved ranges, which may weaken them over time. They are not safe for use in the recalled lots.
Check the model number and lot number on the suture packaging against the list provided in the recall notice.
Contact Covidien directly for assistance with the recall process to determine the next steps.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0845-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0845-2024 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.
