Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves
Fresenius Medical Care recalls a blood pump rotor spare part used in dialysis systems in Canada due to reports of loose or dislodged guide sheaves after use. No injuries have been reported.
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: FDA Class II medical device with no reported illnesses or injuries. The defect—loose guide sheaves in a critical dialysis equipment component—represents a risk-of-harm product where actual injury has not yet been documented. Per rubric criteria, this qualifies as High severity.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the 2008K@HOME HD System blood pump rotor spare part (Model F40015481 Rev A) distributed in Canada. The recall affects 20 units.
Clinic operators reported an increased number of complaints about loose or dislodged guide sheaves on the blood pump rotor after it had been in use. This defect could potentially affect the proper operation of the dialysis system during treatment.
If you have received or are using this blood pump rotor spare part, discontinue use and contact Fresenius Medical Care Holdings, Inc. for a replacement or further instructions.
The recalled product
- Product
- 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- loose-component
- equipment-failure
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: 191014
- UDI/DI: N/A (Canada only)
- Serial Number: 6K0S162351
- 6K0S162352
- 6K0S162353
- 6K0S162354
- 6K0S162355
- 6K0S169113
- 6K0S169114
- 6K0S169115
- 6K0S169116
- 6K0S169117
- 6K0S169118
- 6K0S169119
- 6K0S169120
- 6K0S169121
- 6K0S169122
- 6K0S169123
- 6K0S169124
- 6K0S169125
Distribution
Distributed nationwide across the United States.
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