Class II

Medical Device Recall: 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Fresenius Medical Care Holdings, Inc. · June 3, 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

Domestic: Nationwide Distribution. International: Canada.

States Affected

NATIONWIDE

Quantity Affected

372 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2340-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.