AMD Medicom Inc. recalls HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item
Recalled Product
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
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: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;
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