HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
FDA Recall #Z-1147-2024 — Class II — December 21, 2023
Product Description
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
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.
Recalling Firm
AMD Medicom Inc. — Montreal, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
960 cases (10 boxes/case and 50 masks/box)
Distribution
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Code Information
Item Code: 570-3281; UDI DI: 10304040168629; Lot #s: 2340, 2341, 2342;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated