Fresenius 2008K Series : Hemodialysis System
FDA Recall #Z-1027-2017 — Class II — December 21, 2016
Product Description
Fresenius 2008K 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
Recalling Firm
Fresenius Medical Care Renal Therapies Group, LLC — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
78481 (US) 2734 units (OUS)
Distribution
Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
Code Information
All serial numbers
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated