Device product
Sterile Custom Packs to be used in surgical procedures.
Z-2175-2020
Product summary
- Event
- Event 85502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,868 total kits
- Official record key
device-enforcement:Z-2175-2020
Official wording
Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA.
Code information: ACS Tray Numbers: AGMV151; Lot # 993201, Exp. Date 01/07/2021 (12 kits) and Lot # 676191,Exp. Date 11/20/2020 (18 kits) WXMV15H; Lot # 663191, Exp. Date 12/03/2020 (32 kits) AGLA66H; Lot # 675191, Exp. Date 11/21/2020 (4 kits) AGLP521; Lot # 648191, Exp. Date 12/18/2020 (6 kits) AGVA31H; Lot # 675191, Exp. Date 11/21/2020 (6 kits) AGIF04F; Lot # 683191, Exp. Date 11/13/2020 (50 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.