FDAFDA · Food and drugs·Recall number Z-1028-2017
Fresenius 2008K2 Series : Hemodialysis System
Published January 25, 2017 · Recall initiated: December 21, 2016
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
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Distributor
- Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
- Lot
- All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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