Device product
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
Z-1409-2017
Product summary
- Firm
- Covidien LLC
- Event
- Event 76327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,750 units
- Official record key
device-enforcement:Z-1409-2017
Official wording
Reason: Sterility compromised due to breach in sterile barrier
Code information: Lot Numbers: 1410577-4 to 1605778
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Sterility compromised