Class II

Medical Device Recall: PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)

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

180 cases (10 boxes/case and 50 masks/box)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1148-2024

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.