Device product
Sterile Custom Packs to be used in surgical procedures.
Z-2174-2020
Product summary
- Event
- Event 85502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2868 total kits
- Official record key
device-enforcement:Z-2174-2020
Official wording
Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA.
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)
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.