Reported Mar 15, 2017 · Terminated
Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in…
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?
- Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ
- Sphere (01-0044) Item Number01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
- Lot codes and dates
- Lot Numbers1410577-4 to 1605778
- Amount recalled
- 42,750 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Sterility compromised due to breach in sterile barrier
This product could cause temporary or reversible health problems — stop using it.
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