FDAFDA · Food and drugs·Recall number Z-1408-2017
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
Published March 15, 2017 · Recall initiated: January 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility compromised due to breach in sterile barrier
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- Nationwide
- Lot
- Lot Numbers: 1112351 to 1609891
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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