Covidien recalls Polysorb Braided Absorbable Suture 2-10 UNDYED 36" GS-21 (Lot A9K0004Y) due to potential packaging issues affecting sterility or humidity. Affected medical devices may cause infection or contamination.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Covidien is recalling a specific type of surgical suture because its packaging might not keep it sterile or dry enough. This could lead to infections or contamination during surgery if the suture is used improperly.
The packaging might not properly protect the suture from moisture or contamination, which could compromise its sterility. If the suture is not sterile when used, it may cause infections or other complications during surgery.
Surgical teams and hospitals using the specific suture model (Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21) with Lot A9K0004Y are affected. Patients undergoing surgery with this suture are at risk of infection or contamination.
Check for the product name 'Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21' with Item Code CL953. The specific lot number A9K0004Y and expiration date of September 30, 2024, are also key identifiers.
Verify the product name, item code, lot number, and expiration date to confirm if it matches the recalled items.
The recall indicates potential packaging issues that could affect sterility or humidity, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact the manufacturer directly for guidance.
Look for the product name 'Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21', item code CL953, lot number A9K0004Y, and expiration date September 30, 2024.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1285-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1285-2020 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.