Recall Z-1325-2016— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-1325-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-10

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2016-03-10, terminated 2017-03-09. It names 5 FDA 510(k) clearances: K121341, K120505, K120017 and 2 more. Product: Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy. Reason: Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12).

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Terminated: 2017-03-09
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

Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy

Reason for recall

Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)

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