AMD Medicom Inc. recalls HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

Recall date

December 21, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1146-2024

FDA classification

Class II

Brand / firm

AMD Medicom Inc.

Sold / distributed

US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.

Why it was recalled

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)