Device product
Custom Packs to be used in surgical procedures.
Z-2168-2020
Product summary
- Event
- Event 85502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2, 868 total kits
- Official record key
device-enforcement:Z-2168-2020
Official wording
Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA.
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)
Distribution pattern: US Nationwide distribution including in the state of Pennsylvania.
Derived failure modes
-
Unknown
The surgical gowns were manufactured in a facility that is not registered by the FDA.