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
This recall has been terminated (originally issued May 13, 2014).
- Recall Initiated
- April 25, 2014
- Posted
- May 13, 2014
- Terminated
- May 18, 2021
- Recall Number
- Z-1619-2014
- Quantity
- 39 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Distribution
USA (nationwide) and the country of Canada.*
Lot / Code Info
Revision K Actuator Test Boards
Root Cause
Device Design
Action Taken
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.