Device product
Sterile Custom Packs to be used in surgical procedures.
Z-2176-2020
Product summary
- Event
- Event 85502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2868 total kits
- Official record key
device-enforcement:Z-2176-2020
Official wording
Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA.
Code information: ACS Tray Numbers: AGSBOO6K; Lot # 660191, Exp. Date 12/06/2020 (19 kits) AGDB14J; Lot # 737191, Exp. Date 09/20/2020 (2 kits) AHLA17J; Lot # 653191, Exp. Date 12/13/2020 (12 kits) SVNE16K; Lot # 691191, Exp. Date 11/05/2020 (20 kits) WPLA17I; Lot # 685191, Exp. Date 11/11/2020 (2 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.