FDAFDA · Food and drugs·Recall number Z-1147-2024
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
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: 570-3281; UDI DI: 10304040168629; Lot #s: 2340, 2341, 2342;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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