Class II
Medical Device Recall: 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Fresenius Medical Care Holdings, Inc. · April 17, 2024
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
12,292 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1868-2024
Status: ongoing
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