Z-2174-2020 Class II Terminated
FDA device recall Z-2174-2020 was initiated by American Contract Systems on April 13, 2020 and is designated Class II. Reason for recall: The surgical gowns were manufactured in a facility that is not registered by the FDA. The recall status is terminated (terminated November 25, 2020). Affected quantity: 2868 total kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 13, 2020
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2868 total kits
Product Description
Sterile Custom Packs to be used in surgical procedures.
Reason for Recall
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Distribution Pattern
US Nationwide distribution including in the state of Pennsylvania.
Code Information
ACS Tray Numbers: FBCS38I; Lot # 692191, Exp. Date 11/04/2020 (4 kits) and Lot # 648191,Exp. Date 12/18/2020 (40 kits)