Device product
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Z-1148-2024
Product summary
- Firm
- AMD Medicom Inc.
- Event
- Event 93818
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 180 cases (10 boxes/case and 50 masks/box)
- Official record key
device-enforcement:Z-1148-2024
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: 127-7573; UDI DI: D6620712775732; Lot #s: 2339, 2342;
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.