2008T BlueStar Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component
Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended 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: FDA Class II recall with no reported illnesses or injuries. The defect—loose or dislodged guide sheaves in a blood pump rotor—presents a risk of harm in a life-sustaining hemodialysis device, 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 334 2008T BlueStar Hemodialysis Machines, Model 191128, due to defects in the blood pump rotor component (Model F40015481 Rev A). After extended use in clinical settings, an increased number of complaints have been reported regarding loose or dislodged guide sheaves within the rotor assembly.
Hemodialysis machines are life-sustaining equipment used to filter waste and excess water from the blood of patients with kidney disease. A loose or dislodged guide sheath in the blood pump rotor could potentially compromise the machine's function during treatment.
The recalled machines were distributed nationwide to dialysis clinics throughout the United States. Clinics using affected machines should contact Fresenius Medical Care for guidance on inspection, repair, or replacement of the defective rotor component.
The recalled product
- Product
- 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- dislodged-component
- 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: 191128
- UDI/DI: 00840861102105
- Serial Numbers: 3T0S274210
- 1T0S260183
- 1T0S260455
- 1T0S260456
- 1T0S260485
- 1T0S260273
- 1T0S260283
- 1T0S260490
- 1T0S260158
- 1T0S260182
- 1T0S260266
- 3T0S269011
- 3T0S273223
- 3T0S274216
- 3T0S274225
- 3T0S274678
Distribution
Distributed nationwide across the United States.
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