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
Reported: May 21, 2014 Initiated: April 25, 2014 #Z-1619-2014
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
Reason for Recall
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 39 units
- Distribution
- USA (nationwide) and the country of Canada.*
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 39 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-1619-2014.
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