Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1551-2015)

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: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP 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-1551-2015

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: 0K0S-0009 0K0S-0011- 0015 0K0S-0018 0K0S-0019 0K0S-0021- 0028 0K0S-0030- 0032 0K0S-0034- 0036 0K0S-0038- 0040 0K0S-0042 0K0S-0044- 077 0K0S-0080- 278 0K0S-0280- 285 0K0S-0287- 478 0K0S-0480- 552 0K0S-0554- 677 0K0S-0679- 884 0K0S-0886- 900 0K0S-0902- 916 0K0S-0918 0K0S-0920 0K0S-0921 0K0S-0923- 926 0K0S-0928- 934 0K0S-0936- 942 0K0S-0944- 958 0K0S-0961 0K0S-0962 0K0S-0964- 991 0K0S-0993- 0999 1K0S-1001- 4999 2K0S-5000- 9999 2K0S-A000- A999 2K0S-B000- B999 3K0S-C000- C999 3K0S-D000- D999 3K0S-E000- E999 3K0S-F000- F999 3K0S-G000- G999 3KOS-H000- H999 4H0S-J275 4K0S-J000- J999 4K0S-K000- K999 4K0S-L000- L999 4K0S-M000- M999 4K0S-N000- N999 4K0S-P000- P999 4K0S-Q000- Q999 4K0S-R000- R999 4K0S-S000- S999 4K0S-T615 4KK0S-Q907 50S-W536 5K0S-000A- 999D 5K0S-T000- T999 5K0S-U000- U999 5K0S-V000- V999 5K0S-W000- W999 5K0S-X000- X999 5K0S-Y011- Y999 5K0S-Z000- Z999 5K0-Y176 6K0S-000E- 999E 6K0S-000F- 999E 6K0S-000G- 999E 6K0S-000H- 999H 6K0S-000J- 999J 6K0S-000K- 999K 6K0S-000L- 999L 6K0S-000M- 999M 6K0S-000N- 999N 6K0S-000P- 999P 6K0S-000Q- 999Q 6K0S-000R- 999R 6K0S-000S- 999S 6K0S-000T- 159T 7K0S100001- 115591 7KOS103444 7KOS103556 7KOS104151 7KOS104219 7KOS104293 7KOS104318 8K0S115592- 121299 8K0S121301- 126597 8K0S1269573 8K0S127201- 130767 8K0S130769 8K0S130770- 131327 8K0S131329 8K0S131331 8K0S131333- 1365 8K0S131406- 1411 8K0S131417-1419 8K0S131426 8K0S131448

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated