Z-1409-2017 Class II Terminated
FDA device recall Z-1409-2017 was initiated by Covidien LLC on January 23, 2017 and is designated Class II. Reason for recall: Sterility compromised due to breach in sterile barrier The recall status is terminated (terminated August 7, 2019). Affected quantity: 42,750 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2017
- Initiation Date
- January 23, 2017
- Termination Date
- August 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,750 units
Product Description
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
Reason for Recall
Sterility compromised due to breach in sterile barrier
Distribution Pattern
Nationwide
Code Information
Lot Numbers: 1410577-4 to 1605778