FDA-Device2024-02-28Class II
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
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
720 cases (10 boxes/case and 50 masks/box)
Manufactured in
2555 Ch de L'Aviation, N/A, Montreal, N/A, Canada
Products
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1146-2024Don't want to check this manually?
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