Reported Mar 15, 2017 · Terminated
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020…
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 Sterile Drape For Use with Blair-Port Wand (02-0029) and
- Blair-Port Wand X (01-0046) Item Number01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
- Lot codes and dates
- Lot Numbers1112351 to 1609891
- Amount recalled
- 1,111,600 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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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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