Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2346-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Product Classification:

Class II

Date Initiated: June 3, 2024

Date Posted: July 17, 2024

Recall Number: Z-2346-2024

Event ID: 94775

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.

Status: Ongoing

Product Quantity: 2 units

Code Information:

Model Number: RTL190904 (Rental Units); UDI/DI: 00840861100965; Serial Numbers: 5K0S193320, 5K0S194164.

Distribution Pattern:

Domestic: Nationwide Distribution. International: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated