Covidien recalls Polysorb 3/0 VIOLET suture due to potential packaging issues affecting humidity or sterility. Affected lots may not be sterile, risking infection during surgery.
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. This could lead to infections if used in surgery.
The packaging might allow moisture or contaminants to enter, compromising the suture's sterility. This could cause infections during surgery if the suture is not properly sterile.
Surgical professionals using the recalled suture for soft tissue or eye procedures. Patients undergoing surgery with this suture are at risk of infection.
Check for the item code CL461 and lot number D7H0876X on the packaging. The suture is 30 inches (75cm) violet, 3/0 size, used for soft tissue or eye surgery.
Look for the lot number D7H0876X and expiration date 2022-08-31 on the suture packaging.
No, this specific suture is only for soft tissue or eye surgery, not cardiovascular or neural tissue.
The recall does not specify a remedy, so check with your supplier or contact Covidien for guidance.
The recall does not require stopping use, but the packaging issue means it may not be sterile, so consult your surgeon.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1274-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1274-2020 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.
