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FDAApril 17, 2024device

2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

fresenius medical carefreseniusfresenius medical

UPCs

00840861102112

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A — Recall Details · AllClear