PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 21, 2014 Initiated: April 25, 2014 #Z-1618-2014

Product Description

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

Reason for Recall

2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

Details

Units Affected
79 units
Distribution
USA (nationwide) and the country of Canada.*
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 79 units.
Why was this product recalled?
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Which agency issued this recall?
This recall was issued by the FDA Devices on May 21, 2014. Severity: Moderate. Recall number: Z-1618-2014.