FDAFDA · Food and drugs·Recall number Z-1866-2024
Blood Pump Rotor, Model Number: F40015481 Rev A
Published May 29, 2024 · Recall initiated: April 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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