Z-1147-2024 Class II Ongoing
FDA device recall Z-1147-2024 was initiated by AMD Medicom Inc. on December 21, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 960 cases (10 boxes/case and 50 masks/box).
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- December 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 960 cases (10 boxes/case and 50 masks/box)
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.
Distribution Pattern
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;