Device product
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Z-1146-2024
Product summary
- Firm
- AMD Medicom Inc.
- Event
- Event 93818
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 720 cases (10 boxes/case and 50 masks/box)
- Official record key
device-enforcement:Z-1146-2024
Official wording
Reason: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Code information: Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;
Distribution pattern: US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Derived failure modes
-
Unknown
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.