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.
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 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.
- Affected units
- 334
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.
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
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