Device product
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Z-0838-2022
Product summary
- Event
- Event 89691
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 74 cases
- Official record key
device-enforcement:Z-0838-2022
Official wording
Reason: Transport company failed to stop at the border for required FDA inspection.
Code information: Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604
Distribution pattern: U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
Derived failure modes
-
Unknown
Transport company failed to stop at the border for required FDA inspection.