Covidien recalls specific mild chromic gut absorbable sutures due to potential unsterile product from supplier calibration issues. Use may cause infection or vision loss in eye procedures. Affected items have GTINs and specific lots.
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
Covidien is recalling certain mild chromic gut absorbable sutures because they may not have been properly sterilized during manufacturing. This could lead to infections or, if used in eye surgeries, cause vision loss.
The sutures were produced by a supplier with a calibration issue during sterilization, which may result in unsterile product. Using unsterile sutures can cause infections, and in eye procedures, this could lead to permanent vision loss.
Surgical professionals and patients who use these sutures for medical procedures are affected. Those using the sutures in eye surgeries face the highest risk of vision loss.
Check for the product names: Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K) or CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K). Look for GTINs 20884521054339 or 20884521054438 and lots D2H0095ZY or D2H0096ZY.
Identify the product name, GTIN, and lot number to confirm if your sutures are affected.
Covidien was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product.
Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a risk of vision loss.
Check for the product names: Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K) or CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K). Look for GTINs 20884521054339 or 20884521054438 and lots D2H0095ZY or D2H0096ZY.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1389-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1389-2023 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.
