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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius 2008T Hemodialysis Machine

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 Class 2 Device Recall Fresenius 2008T Hemodialysis Machine see related information
Date Posted May 13, 2014
Recall Status1 Open
Recall Number Z-1618-2014
Recall Event ID 68042
510(K)Number K121341 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
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
Code Information 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
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
FDA Determined
Cause 2
Device Design
Action 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.
Quantity in Commerce 79 units
Distribution USA (nationwide) and the country of Canada.*
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE, NORTH AMERICA
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