AMD Medicom Inc. Recall 93818
Description: PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
AMD Medicom Inc. Recall 93818 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1148-2024 |
| Event ID | 93818 |
| Event Description | PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX. |
| Quantity | 180 cases (10 boxes/case and 50 masks/box) |
| Recall Reason | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| Device Classification | 20240228 |
| Device Code Info | Item Code: 127-7573; UDI DI: D6620712775732; Lot #s: 2339, 2342; |
| Center Classification Date | 20240216 |
| Recall Initiation Date | 20231221 |
| Recalling Firm | AMD Medicom Inc. |
| Initial Notification | Letter |
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