2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Reported: May 29, 2024 Initiated: April 17, 2024 #Z-1869-2024
Product Description
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Reason for Recall
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 334 units
- Distribution
- US Nationwide distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 334 units.
Why was this product recalled? ▼
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-1869-2024.
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