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AMD Medicom Inc. recalls PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Recalled February 28, 2024 · FDA recall Z-1148-2024 · 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
180 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
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Manufacturer(s)
AMD Medicom Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →