HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Reported: February 28, 2024 Initiated: December 21, 2023 #Z-1146-2024
Product Description
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
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.
Details
- Recalling Firm
- AMD Medicom Inc.
- Units Affected
- 720 cases (10 boxes/case and 50 masks/box)
- Distribution
- US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
- Location
- Montreal, N/A
Frequently Asked Questions
What product was recalled? ▼
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448). Recalled by AMD Medicom Inc.. Units affected: 720 cases (10 boxes/case and 50 masks/box).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2024. Severity: Moderate. Recall number: Z-1146-2024.
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