FDAFDA · Food and drugs·Recall number Z-1619-2014
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
Published May 21, 2014 · Recall initiated: April 25, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- USA (nationwide) and the country of Canada.*
- Lot
- Revision K Actuator Test Boards
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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