FDA Device recall Z-1148-2024
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) by Amd Medicom, citing level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1148-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-21 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Amd Medicom |
| Distribution | US |
Product
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
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.
Identifiers
| code_info | Item Code: 127-7573; UDI DI: D6620712775732; Lot #s: 2339, 2342; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2024%22
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