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U.S. Department of Health and Human Services

Class 2 Device Recall Revision K Actuator Test Boards

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 Class 2 Device Recall Revision K Actuator Test Boardssee related information
Date Initiated by FirmApril 25, 2014
Date PostedMay 13, 2014
Recall Status1 Terminated 3 on May 18, 2021
Recall NumberZ-1619-2014
Recall Event ID 68042
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductRevision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
Code Information Revision K Actuator Test Boards 
FEI Number 3001451489
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
ActionFresenius 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 Commerce39 units
DistributionUSA (nationwide) and the country of Canada.*
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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