HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AMD Medicom Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Product Codes/Lot Numbers:
Item Code: 570-2448; UDI DI: 10304040142520; Lot #s: 2337, 2338, 2342, 2343, 2344;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1146-2024
Related Recalls
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.