Covidien recalls Polysorb 4/0 3:0 VIO SC-2 suture due to potential packaging issues affecting humidity or sterility. Affected lots may not be sterile when used in 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 some packaging might not keep it sterile or dry enough. This could lead to infections or other complications 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 in surgery, it could cause infections or other complications.
Surgical professionals and patients who use this suture for soft tissue procedures or eye surgeries. Those with the specific lot number D7H0946X are most at risk.
Check the lot number on the packaging, which should be D7H0:946X. The product is labeled as Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K with item code SL654. It expires by August 31, 2022.
Look for the lot number D7H0946X on the packaging to confirm if it's affected.
No, this suture is specifically indicated for soft tissue approximation or eye surgeries, not cardiovascular or neural tissue.
The recall does not specify a remedy, so check the lot number and contact the manufacturer if you have concerns.
The affected lot number is D7H0946X; check the packaging for this number.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1296-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1296-2020 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.