Blood Pump Rotor for Hemodialysis System Recalled for Loose Components
Fresenius Medical Care is recalling Blood Pump Rotor components used in hemodialysis systems after reports of loose or dislodged guide sheaves during use. The defect affects 372 units distributed nationwide and in Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is an FDA Class II recall for a medical device component (blood pump rotor) with reported mechanical failure (loose or dislodged guide sheaves). No illnesses or injuries have been reported; the recall addresses a risk-of-harm condition where the mechanical defect could affect device functionality during hemodialysis treatment.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the Blood Pump Rotor (Model 190904, Part Number F40015481 Rev A) used in the 2008K@HOME Hemodialysis System. The recall was initiated after clinics reported an increased number of complaints involving loose or dislodged guide sheaves on the blood pump rotor following a period of use.
Approximately 372 units of the affected component have been distributed in the United States and Canada. The specific serial numbers affected have been identified by Fresenius and are available through the FDA recall notice.
Clinics and healthcare facilities using these hemodialysis systems should contact Fresenius Medical Care immediately to determine if their units are affected based on the serial numbers listed. Users should discontinue use of affected units and follow the manufacturer's instructions for replacement or further guidance.
The recalled product
- Product
- 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 372
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: 190904
- UDI/DI: 00840861100965
- Serial Numbers: 5K0S194173
- 7K0S300085
- 4K0S190310
- 4K0S190311
- 4K0S190312
- 4K0S190314
- 4K0S190315
- 4K0S190318
- 4K0S190321
- 4K0S192510
- 4K0S192511
- 4K0S192812
- 4K0S192813
- 4K0S192814
- 4K0S192815
- 4K0S192816
- 4K0S192817
- 4K0S192818
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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