PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
FDA Recall #Z-1148-2024 — Class II — December 21, 2023
Product Description
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
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
180 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: 127-7573; UDI DI: D6620712775732; Lot #s: 2339, 2342;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated