Apr

2018

Fresenius Liberty Select Cycler (SW v.2.8.7) Cl II

Company:Fresenius Medical Care Renal Therapies Group, LLC
Date of Enforcement Report 4/18/2018
Class lI:

PRODUCT

Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Recall Number Z-1365-2018

REASON
The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.

RECALLING FIRM/MANUFACTURER
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA on 1/24/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9293

DISTRIBUTION
Nationwide

___________________________________

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 Liberty Select Cycler (SW v.2.8.7) Cl II

Amy Sellers

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