Reported Mar 8, 2023 · Ongoing
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
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?
- Custom Suture Pack Product DescriptionUS1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
- Lot codes and dates
- GTINN/A Model Number Lot #
- US1638
A1K0289YA1K0291YUS1638 A1K0283Y
- US1756A2E0454Y
- Amount recalled
- 9606
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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