Fresenius Hemodialysis Machines Recalled for Potential UF Pump Detection Failure
Fresenius Medical Care is recalling 79 hemodialysis machines and replacement parts because they may fail to detect a disconnected Ultrafiltration (UF) Pump.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a critical safety function (UF pump detection) in a life-sustaining medical device, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 79 units of the Fresenius 2008T Hemodialysis Machine equipped with Revision K Actuator Test Boards. These units are also sold as replacement parts for use with other Fresenius 2008-Series Hemodialysis Machines, including the 2008K, 2008K2, 2008K@home, and 2008T models. The specific part number for the affected boards is 190234 Revision K.
The recall was initiated because the machines may fail to detect a disconnected Ultrafiltration (UF) Pump. This defect could compromise the machine's ability to monitor fluid removal during dialysis. The affected products were distributed nationwide in the United States and in Canada.
Patients and healthcare facilities should identify affected units by checking the serial numbers of the 2008T machines against the list provided in the official recall notice. The recall number for this action is Z-1618-2014. Users should contact Fresenius Medical Care for instructions on how to resolve the issue.
The recalled product
- Product
- 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
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 79
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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