Device product
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Z-2626-2023
Product summary
- Event
- Event 92942
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 41790 masks
- Official record key
device-enforcement:Z-2626-2023
Official wording
Reason: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Code information: UDI-DI: 20680651468271; Lot Number AM2164811
Distribution pattern: US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia
Derived failure modes
-
Unknown
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.