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 |
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