Recall Z-1550-2015— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1550-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-20

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2015-02-20, terminated 2021-05-18. It names 5 FDA 510(k) clearances: K121341, K120505, K120017 and 2 more. Product: 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.. Reason: 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..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-20
Terminated: 2021-05-18
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

5 on FDA's record

K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America·cleared 2012-12-06
K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America, Design Cente·cleared 2012-03-06
K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America·cleared 2012-02-02
K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America·cleared 2011-12-21
K080964 — FRESENIUS MODEL 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America·cleared 2009-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.