Fresenius Medical Care Holdings, Inc. Recall 94463
Description: Blood Pump Rotor, Model Number: F40015481 Rev A
Fresenius Medical Care Holdings, Inc. Recall 94463 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1866-2024 |
| Event ID | 94463 |
| Event Description | Blood Pump Rotor, Model Number: F40015481 Rev A |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 45,880 components |
| Recall Reason | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. |
| Device Classification | 20240529 |
| Device Code Info | Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. |
| Center Classification Date | 20240517 |
| Recall Initiation Date | 20240417 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
| Similar To |