Jan

2017

Fresenius 2008 Series Hemodialysis Systems Cl II

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Fresenius 2008 Series Hemodialysis Systems Cl II

Amy Sellers

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