Hemodialysis Blood Pump Rotor Spare Part Recalled for Loose Sheaves
Fresenius Medical Care is recalling hemodialysis blood pump rotor spare parts due to reports of loose or dislodged guide sheaves. The affected model is distributed nationwide in the U.S. and 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 a Class II FDA recall for a critical dialysis equipment component. Although no reported illnesses or injuries are documented in the source, the potential for equipment malfunction during dialysis treatment poses a significant risk to patient safety. The recall meets the rubric criterion for a 'risk-of-harm product where injury has not yet been reported.'
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling blood pump rotor spare parts (Model RTL190828, Model Number F40015481 Rev A) for its 2008K@HOME hemodialysis system. These are critical components of dialysis equipment used in clinical settings.
An increased number of complaints were reported regarding the blood pump rotor. Specifically, guide sheaves were found to become loose or dislodged after a period of use in dialysis clinics. A loose or dislodged rotor component could result in equipment malfunction during patient treatment.
The recalled spare parts were distributed nationwide in the United States and internationally in Canada. Healthcare providers and dialysis clinics should verify whether their equipment includes the affected model.
Clinics and healthcare providers are advised to contact Fresenius Medical Care Holdings, Inc. for instructions regarding inspection, replacement, or other remedial measures.
The recalled product
- Product
- RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 1
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 (3)
- Model Number: RTL190828 (Rental Units)
- UDI/DI: 00840861100941
- Serial Number: 1K0S172181
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.
See all 8 products in this recall →Related recalls
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