Blood Pump Rotor Spare Part Recall Due to Loose Guide Sheaves
Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.
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: FDA Class II medical device recall of a critical dialysis component with reported mechanical failure (loose/dislodged guide sheaves) that poses a risk of harm. No illnesses or injuries have been reported, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the Blood Pump Rotor spare part (Model Number F40015481 Rev A), which is used in K@HOME dialysis machines. A total of 17 units have been distributed nationwide in the United States and in Canada.
The company received multiple complaints from dialysis clinics reporting that the guide sheaves (components of the blood pump rotor) became loose or dislodged after a period of use. A loose or dislodged sheave could interfere with proper blood pump operation during dialysis treatment.
Dialysis clinics and patients using affected K@HOME machines should immediately cease use of the affected rotor units and contact their Fresenius equipment representative. Patients should request a replacement rotor to ensure safe continuation of dialysis therapy. The FDA has classified this recall as Class II.
The recalled product
- Product
- RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 17
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 (19)
- Model Number: RTL190395 (Rental Units)
- UDI/DI: 00840861100958
- Serial Numbers: 4K0S-R138
- 5K0S-Z652
- 5K0S-462B
- 5K0S-Z669
- 6K0S-505F
- 6K0S-513F
- 6K0S-850G
- 6K0S-480J
- 6K0S-467K
- 6K0S-995P
- 7K0S103784
- 6K0S-009M
- 7K0S110463
- 7K0S110427
- 7K0S110771
- 6K0S-725R
- 6K0S-324L
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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