Covidien recalls Polysorb Braided Absorbable Suture UD 4/0 18 P-13 (Item SL5690) due to potential packaging issues affecting humidity or sterility. Affected lots D7G2298X (exp 2022-07-31) and D7H0091X (exp 2022-08-31) may not be sterile.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Covidien is recalling specific lots of Polysorb suture for possible packaging defects that could compromise sterility or humidity control. This could lead to infections if the suture is used improperly.
The packaging may allow moisture or contaminants to enter, potentially compromising the sterility of the suture. This could lead to infections if the suture is used in procedures where sterility is critical.
Surgical professionals and medical facilities using the recalled suture lots for soft tissue procedures. Patients using the suture in ophthalmic surgery are at risk if the product is not sterile.
Check the lot number on the packaging: D7G2298X (expires July 31, 2022) or D7H0091X (expires August 31, 2022). The product is used for soft tissue procedures like ophthalmic surgery.
Look for lot numbers D7G2298X or D7H0091X on the packaging.
No, this specific lot has packaging issues that could affect sterility. It is intended for soft tissue procedures like ophthalmic surgery, not cardiovascular or neural tissue.
The recall does not specify a remedy, so contact the manufacturer for guidance if you have the affected lot numbers.
Only if the packaging is intact and the product is not expired. However, the recall indicates potential sterility risks, so it is recommended to check the lot number and contact the manufacturer.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1295-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1295-2020 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.
