Z-1028-2017 Class II Terminated
FDA device recall Z-1028-2017 was initiated by Fresenius Medical Care Renal Therapies Group, LLC on December 21, 2016 and is designated Class II. 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… The recall status is terminated (terminated March 17, 2023). Affected quantity: 60,151 units (US) 1773 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2017
- Initiation Date
- December 21, 2016
- Termination Date
- March 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,151 units (US) 1773 (OUS)
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
Distribution Pattern
Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
Code Information
All serial numbers