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

Hazard

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

Details from the source

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. Quantity: 720 cases (10 boxes/case and 50 masks/box) Lot/code info: Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;

UPC codes

10304040142520

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.