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AMD Medicom Inc. recalls HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Recalled February 28, 2024 · FDA recall Z-1147-2024 · AMD Medicom
Hazard
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. · FDA Class II
Units
960 cases (10 boxes/case and 50 masks/box)
Sold at
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Description
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Product
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Manufacturer(s)
AMD Medicom Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →