FDAFDA · Food and drugs·Recall number Z-1146-2024
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Published February 28, 2024 · Recall initiated: December 21, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AMD Medicom Inc.
- Distributor
- US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
- Lot
- Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.