Fresenius Medical Care Holdings, Inc.: Hemodialysis System Blood Pump Rotor Recalled for Loose or Dislodged Parts

What You Should Do

1. Identify if your dialysis machine is affected by checking the model and serial numbers. This recall impacts 2008K@HOME Hemodialysis Systems with model numbers 190904, 190828, 191014, 190395, and rental/refurbished variants (RTL190395, RTL190828, RTL190904, RTLR190395).
2. Specifically locate the Blood Pump Rotor spare part (P/N F40015481 REV A) and verify if your machine's serial number is among the over 2,000 units listed in the recall notice.
3. Check your machine for any visible signs of loose or dislodged guide sheaves on the blood pump rotor assembly.
4. If your machine is affected, contact Fresenius Medical Care Holdings, Inc. at their Waltham, Massachusetts headquarters or reach out to your local clinical representative for guidance on repairs or replacement parts.
5. Consult with your healthcare provider or home dialysis technician before your next scheduled treatment to ensure the equipment is safe for continued use.
6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products