Z-2168-2020 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
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
WPGA21L; Lot # 998201, Exp. Date 01/02/2021 (24 kits) and Lot # 6781914, Exp date 11/18/2020 (4 kits) AGGL48H; Lot# 643191, Exp. Date 12/23/2020 (80 kits) AGGM59N: Lot # 761191, Exp. Date 08/27/2020 (5 kits)