Z-2176-2020 Class II Terminated
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: AGSBOO6K; Lot # 660191, Exp. Date 12/06/2020 (19 kits) AGDB14J; Lot # 737191, Exp. Date 09/20/2020 (2 kits) AHLA17J; Lot # 653191, Exp. Date 12/13/2020 (12 kits) SVNE16K; Lot # 691191, Exp. Date 11/05/2020 (20 kits) WPLA17I; Lot # 685191, Exp. Date 11/11/2020 (2 kits)