FDA-Device2024-02-28Class II
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
AMD Medicom Inc.
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.
Sold states
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Affected count
180 cases (10 boxes/case and 50 masks/box)
Manufactured in
2555 Ch de L'Aviation, N/A, Montreal, N/A, Canada
Products
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1148-2024Don't want to check this manually?
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