Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2017 - (Recall #: Z-1028-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Fresenius 2008K2 Series : Hemodialysis System

Product Classification:

Class II

Date Initiated: December 21, 2016

Date Posted: January 25, 2017

Recall Number: Z-1028-2017

Event ID: 76037

Reason for Recall:

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Status: Terminated

Product Quantity: 60,151 units (US) 1773 (OUS)

Code Information:

All serial numbers

Distribution Pattern:

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

Voluntary or Mandated:

Voluntary: Firm initiated