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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 Initiated by Firm April 25, 2014
Date Posted May 13, 2014
Recall Status1 Open3, Classified
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/
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE, NORTH AMERICA