Z-1264-2020 Class II Terminated
FDA device recall Z-1264-2020 was initiated by COVIDIEN LLC on January 17, 2020 and is designated Class II. Reason for recall: Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection The recall status is terminated (terminated July 29, 2022). Affected quantity: 2,180 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- January 17, 2020
- Termination Date
- July 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,180 units
Product Description
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Reason for Recall
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Distribution Pattern
US Nationwide, Israel, and Japan
Code Information
Lot Number: P9E0022Y