Fresenius Medical Care Holdings, Inc.: Blood Pump Rotors and Hemodialysis Machines Recalled for Loose Parts

What You Should Do

1. Identify if your facility or home use machine is affected by checking the model and serial numbers. Affected machines include 2008T BlueStar models 191124, 191126, 191128, and 191130, as well as standalone Blood Pump Rotors with model number F40015481 Rev A.
2. For hemodialysis machines, verify your specific serial number against the extensive list of affected units provided in the recall notice (e.g., Serial Numbers starting with 0T0S, 1T0S, 2T0S, 3T0S, or 4T0S).
3. Inspect the blood pump rotor component for any signs of loose or dislodged guide sheaves if you are trained to perform equipment maintenance.
4. If you are a patient, contact your healthcare provider or dialysis clinic immediately to ensure your machine has been inspected or to schedule a component replacement.
5. Contact Fresenius Medical Care Holdings, Inc. at 1-888-463-6332 for further technical instructions or to arrange for necessary repairs and replacements.
6. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding this safety recall.

Your Remedy Options

Affected Products