Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1550-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

Product Classification:

Class II

Date Initiated: February 20, 2015

Date Posted: May 6, 2015

Recall Number: Z-1550-2015

Event ID: 70574

Reason for Recall:

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

Status: Terminated

Product Quantity: 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)

Code Information:

Serial Numbers: 0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated