FDA recall Z-1146-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2023-12-21

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montreal, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1146-2024