Z-2178-2020 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
- 2, 868 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: AGPP38I; Lot # 644191, Exp. Date 12/22/2020 (2 kits) and Lot # 713191, Exp. Date 10/14/2020 (12 kits) AGHA64J; Lot # 663191, Exp. Date 12/03/2020 (72 kits) and Lot # 716191, Exp. Date 10/11/2020 (10 kits) WPBU64H; Lot # 670191, Exp. Date 11/26/2020 (16 kits)