Fresenius 2008K2 Series : Hemodialysis System
Reported: January 25, 2017 Initiated: December 21, 2016 #Z-1028-2017
Product Description
Fresenius 2008K2 Series : Hemodialysis System
Reason for Recall
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
Details
- Recalling Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Units Affected
- 60,151 units (US) 1773 (OUS)
- Distribution
- Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Fresenius 2008K2 Series : Hemodialysis System. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 60,151 units (US) 1773 (OUS).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1028-2017.
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