Reported Jun 8, 2016 · Terminated
Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh…
Covidien LLC
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 LLC · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
Curity Gauze Sponges16 ply 4" x 4" (10.2 cm x 10.2 cm)Sterile 10's in Soft Pouch
- Item Number397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs
- Lot codes and dates
- All lots beginning with 110000037462 through Lot 120002259962
- Amount recalled
- 713600
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
Compromised sterility due to breach of barrier
This product could cause temporary or reversible health problems — stop using it.
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