—#126850

Product

Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K121341
Affected lot / code info: Revision K Actuator Test Boards S/N of 2008 T Machines: 3T0S124903 3T0S124937 3T0S124933 3T0S124986 3T0S124934 3T0S124970 3T0S124894 3T0S124935 3T0S124912 3T0S124965 3T0S124944 3T0S124988 3T0S124939 3T0S124990 3T0S124940 3T0S124941 3T0S124958 3T0S124888 3T0S124946 3T0S124999 3T0S124942 3T0S124991 3T0S125023 3T0S124951 3T0S124936 3T0S124895 3T0S124955 3T0S125000 3T0S124943 3T0S125010 3T0S124893 3T0S124954 3T0S124896 3T0S124899 3T0S124959 3T0S125008 3T0S124947 3T0S125018 3T0S124905 3T0S124961 3T0S124898 3T0S124907 3T0S124963 3T0S124891 3T0S124952 3T0S125028 3T0S124920 3T0S124966 3T0S124910 3T0S124909 3T0S124967 3T0S124901 3T0S124953 3T0S125029 3T0S124922 3T0S124969 3T0S124913 3T0S124911 3T0S124972 3T0S124902 3T0S124960 3T0S124930 3T0S124925 3T0S125011 3T0S124921 3T0S124916 3T0S124979 3T0S124918 3T0S124962 3T0S124945 3T0S124926 3T0S125013 3T0S124927 3T0S124917 3T0S124984 3T0S124928 3T0S124968 3T0S124964 3T0S124932

Why it was recalled

2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

Root cause (FDA determination)

Device Design

Action the firm took

Fresenius Medical issued Urgent Recall letter issued on 4/25/14 by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected 2008T machines or if they have installed any of the affected replacement boards. If customers have the affected machines or replacement boards, they will be instructed to contact FMC-RTG Technical Service to have the Actuator Test Boards replaced. Contact the FMCNA Technical Service Team at 1-800-227-2572.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: USA (nationwide) and the country of Canada.*

Timeline

Recall initiated: 2014-04-25
Posted by FDA: 2014-05-13
Terminated: 2021-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126850. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.