Henry Schein¿ Criterion¿ Anti-fog Earloop Masks Level 3 recall
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Why was Henry Schein¿ Criterion¿ Anti-fog Earloop Masks Level 3 recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Code: 570-3281; UDI DI: 10304040168629; Lot #s: 2340, 2341, 2342;
- Product
- HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
- Recalling firm
- AMD Medicom Inc.
- Quantity
- 960 cases (10 boxes/case and 50 masks/box)
- Distribution
- US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
- Recall date
- February 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)