Draeger Medical, Inc. Recall 91538
Description: NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Draeger Medical, Inc. Recall 91538 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1138-2023 |
| Event ID | 91538 |
| Event Description | NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L) |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 893 units |
| Recall Reason | The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants. |
| Device Classification | 20230301 |
| Device Code Info | All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581) |
| Center Classification Date | 20230223 |
| Recall Initiation Date | 20230123 |
| Recalling Firm | Draeger Medical, Inc. |
| Initial Notification | Letter |
| Similar To |