Device product
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Z-1059-2023
Product summary
- Event
- Event 91530
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 73 cases
- Official record key
device-enforcement:Z-1059-2023
Official wording
Reason: Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
Code information: UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
Distribution pattern: US distribution to IL, NC, NY, OH, and PA.
Derived failure modes
-
Labeling or packaging
incorrectly labeled