Class II

Medical Device Recall: RTL190904: 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

2 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2346-2024

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.

Fresenius Medical Care Holdings, Inc. Medical Device Recall: RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | SafeCheck