Z-1408-2017 Class II Terminated
FDA device recall Z-1408-2017 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: 1,111,600 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
- 1,111,600 units
Product Description
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
Reason for Recall
Sterility compromised due to breach in sterile barrier
Distribution Pattern
Nationwide
Code Information
Lot Numbers: 1112351 to 1609891