medical Class II Updated 2024-02-28

AMD Medicom Inc. recalls HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLU

Recalled Product

HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)


Hazard / Issue

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Item Code: 570-3281; UDI DI: 10304040168629; Lot #s: 2340, 2341, 2342;
View official government recall

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