Covidien recalls specific Novafil sutures due to potential infection or vision loss from sterile barrier breaches during eye surgery. Affected products include various model numbers and lot codes.
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Covidien is recalling certain Novafil sutures that may have a sterile barrier breach in the breather pouch. This could lead to infection or vision loss during eye surgery if the suture comes into direct contact with the patient.
The sterile barrier pouch in the suture may breach during use, allowing contaminants to enter the surgical site. If the suture touches the patient directly, this could cause infection or vision damage during eye surgery.
Surgical professionals and patients undergoing ophthalmic procedures who use the recalled Novafil sutures. Those with the specific model numbers and lot codes listed are most at risk.
Check the product label for model numbers like 8886400241, 8886440013, or lot codes such as D1G1762FY. The recall includes specific suture sizes and colors (blue) with GTIN numbers listed in the product description.
Look for model numbers and lot codes on the suture packaging, such as 8886400241 or D1G1762FY.
Reach out to Covidien directly for assistance with the recall if you have the specific model or lot codes listed.
The sterile barrier pouch may breach during use, potentially causing infection or vision loss if the suture contacts the patient during eye surgery.
Affected models include 8886400241, 8886440013, 8886440023, and others with specific lot codes like D1G1762FY.
No, but you should check your product label and contact Covidien if you have the affected model or lot codes to ensure safety.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1175-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1175-2023 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.
