Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component
Fresenius recalls 931 BlueStar hemodialysis machines due to loose guide sheaves in blood pump rotors. Facilities should immediately discontinue use of affected units.
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 recall of a critical medical device component. While no illnesses or injuries have been reported, loose or dislodged sheaves in a blood pump rotor represent a risk of harm to patients dependent on hemodialysis treatment.
Plain-English summary
Fresenius Medical Care is recalling 931 BlueStar hemodialysis machines (Model 191124) with affected blood pump rotor components (Part Number F40015481 Rev A). An increased number of complaints have been reported regarding loose or dislodged guide sheaves in the blood pump rotor after the machines have been in use.
The recalled units were distributed nationwide in the United States. Healthcare facilities currently operating affected machines should immediately discontinue use and contact Fresenius Medical Care for repair or replacement instructions. Patients and facility staff should not operate machines with the listed affected serial numbers.
The recalled product
- Product
- 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Hemodialysis
- Hazard
- component-dislodgement
- mechanical-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)
- Component: Model Number: F40015481 Rev A
- UDI/DI: N/A
- All Rev A lots. Finished Devices: Model Number: 191124
- UDI/DI: 00840861102082
- Serial Numbers: 0T0S252551
- 0T0S252801
- 0T0S252806
- 1T0S255908
- 1T0S256180
- 0T0S251792
- 0T0S251809
- 0T0S251811
- 0T0S252810
- 0T0S251585
- 0T0S251883
- 0T0S251899
- 1T0S256179
- 1T0S256183
- 1T0S256184
- 1T0S256185
Distribution
Distributed nationwide across the United States.
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