Class II
Medical Device Recall: HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
AMD Medicom Inc. · December 21, 2023
Reason for Recall
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Distribution
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
States Affected
NATIONWIDE
Quantity Affected
720 cases (10 boxes/case and 50 masks/box)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1146-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.