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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 Recall
Revision K Actuator Test Boards
see related information
Date Posted May 13, 2014
Recall Status1 Open
Recall Number Z-1619-2014
Recall Event ID 68042
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Product Revision 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
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham, Massachusetts 02451-1521
Manufacturer Reason
for Recall
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
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 39 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
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