Reported Feb 28, 2024 · Ongoing
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
AMD Medicom Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AMD Medicom Inc. · 2555 Ch de L'Aviation · Montreal, N/A · N/A
Is this the product you have?
- HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
- Lot codes and dates
- Item Code570-2448
- UDI DI
10304040142520Lot #s: 23372338234223432344
- Amount recalled
- 720 cases (10 boxes/case and 50 masks/box)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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