Device product
Sterile Custom Packs to be used in surgical procedures.
Z-2171-2020
Product summary
- Event
- Event 85502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2868 total kits
- Official record key
device-enforcement:Z-2171-2020
Official wording
Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA.
Code information: ACS Tray Numbers: AGLH66F; Lot # 674191, Exp. Date [date] (244 kits) AGAD45I; Lot# 681191, Exp. Date 11/15/2020 (35 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.