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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