Device product
Sterile Custom Packs to be used in surgical procedures.
Z-2172-2020
Product summary
- Event
- Event 85502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2868 kits total
- Official record key
device-enforcement:Z-2172-2020
Official wording
Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA.
Code information: ACS Tray Numbers: AGD1401; Lot # 647191, Exp. Date 06/31/2020 (72 kits) and Lot # 685191 Exp. Date 03/31/2020 (6 kits) WPP147H; Lot # 684191, Exp. Date 11/12/2020 (20 kits) and Lot # 723191 Exp. Date 10/04/2020 (4 kits) SVOH38N; Lot # 654191, Exp. Date 12/12/2020 (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.