Device product
Sterile Custom Packs to be used in surgical procedures.
Z-2167-2020
Product summary
- Event
- Event 85502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,868 total kits
- Official record key
device-enforcement:Z-2167-2020
Official wording
Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA.
Code information: ACS Tray Numbers: AGCY21I; Lot # 664191, Exp. date 12/02/20 (72 kits) WXCY21F; Lot # 661191, Exp. date 12/05/20 (32 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.