Device product
Sterile Custom Packs to be used in surgical procedures.
Z-2179-2020
Product summary
- Event
- Event 85502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,868 total kits
- Official record key
device-enforcement:Z-2179-2020
Official wording
Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA.
Code information: ACS Tray Numbers: AVLC19G; Lot # 642191, Exp. Date 12/24/2020 (64 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.