FDAFDA · Food and drugs·Recall number Z-1409-2017
Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 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: 1410577-4 to 1605778
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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