Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1619-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 25, 2014

Date Posted: May 21, 2014

Recall Number: Z-1619-2014

Event ID: 68042

Reason for Recall:

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

Status: Terminated

Product Quantity: 39 units

Code Information:

Revision K Actuator Test Boards

Distribution Pattern:

USA (nationwide) and the country of Canada.*

Voluntary or Mandated:

Voluntary: Firm initiated