Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves
Fresenius Medical Care is recalling approximately 1,156 blood pump rotor spare parts (Model F40015481 Rev A) distributed in the U.S. and Canada due to reports of loose or dislodged guide sheaves after clinical use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a blood pump component critical to dialysis treatment. Although no illnesses or injuries have been reported, the loose or dislodged guide sheaves represent a material risk of device malfunction that could potentially compromise patient safety.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the Blood Pump Rotor spare part (Model F40015481 Rev A). This component is used in dialysis machine systems, specifically the 2008K@HOME machine.
Clinics reported an increased number of complaints indicating that the blood pump rotor develops loose or dislodged guide sheaves after a period of clinical use. This mechanical failure could affect the device's operation during dialysis treatment.
Approximately 1,156 units were distributed throughout the United States and Canada. Affected healthcare facilities should identify units using the serial numbers provided in the recall notice and contact Fresenius Medical Care Holdings, Inc. for further guidance on inspection or replacement.
The recalled product
- Product
- 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- loose-component
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: 190395
- UDI/DI: 00840861100958
- Serial Number: 6K0S-985P
- 7K0S107747
- 6K0S-021M
- 7K0S103530
- 6K0S-780R
- 6K0S-192E
- 6K0S-217E
- 7K0S102986
- 7K0S110138
- 7K0S110142
- 7K0S106422
- 4K0S-P981
- 4K0S-N154
- 4K0S-N157
- 4K0S-Q697
- 5K0S-V190
- 5K0S-V199
- 6K0S-012R
Distribution
Distributed nationwide across the United States.
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