Reported Apr 19, 2023 · Ongoing
Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
Mild Chromic Gut Absorbable SuturesCH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K)CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
- Lot codes and dates
- GTIN
2088452105433920884521054438
- Lot
D2H0095ZYD2H0096ZY
- GTIN
- Amount recalled
- 960 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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