Company: Fresenius Medical Care Renal Therapies Group, LLC
Date of Enforcement Report 1/25/2017
Class lI:

PRODUCT

Fresenius 2008T Series Hemodialysis System
Recall Number Z-1026-2017 through Z-1029-2017

REASON
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/MANUFACTURER
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA on 12/21/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
Nationwide and Internationally

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