Blood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves
Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed 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 is an FDA Class II medical device recall affecting a critical blood pump component used in life-support dialysis equipment. While no adverse events are explicitly reported in the recall notice, loose or dislodged guide sheaves pose a documented risk of device malfunction. The mechanical failure was confirmed across multiple units during clinical use.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 6 blood pump rotor spare parts (Model F40015481 Rev A) used in dialysis machines. The recalled rotors are at risk of developing loose or dislodged guide sheaves after a period of use in clinical settings.
The specific units affected have the following serial numbers: 6K0S-514F, 6K0S-472G, 6K0S-052M, 6K0S-058N, 5K0S-322B, and 5K0S-U131. These components were distributed nationwide in the United States and in Canada.
Dialysis facilities currently using affected rotor components should discontinue use and contact Fresenius Medical Care Holdings, Inc. for replacement parts or additional guidance. Patients should consult with their healthcare provider if they have questions about whether they may have been affected by this recall.
The recalled product
- Product
- RTLR190395: 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
- mechanical-failure
- 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 (8)
- Model Number: RTLR190395 (Refurbished Rental units)
- UDI/DI: 00840861100958
- Serial Numbers: 6K0S-514F
- 6K0S-472G
- 6K0S-052M
- 6K0S-058N
- 5K0S-322B
- 5K0S-U131.
Distribution
Distributed nationwide across the United States.
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