Device product
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
Z-1408-2017
Product summary
- Firm
- Covidien LLC
- Event
- Event 76327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,111,600 units
- Official record key
device-enforcement:Z-1408-2017
Official wording
Reason: Sterility compromised due to breach in sterile barrier
Code information: Lot Numbers: 1112351 to 1609891
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Sterility compromised