24
May
2012

Cl ll Fresenius Liberty Cycler Software

0

Company:Fresenius Medical Care Holdings, Inc.
Date of Enforcement Report 5/23/12
Class ll:

PRODUCT
Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is intended for acute or chronic peritoneal dialysis. Product Codes: Cyclers: 180020, 180111 User Manuals: 480001 Handi-Guides: 480017. Recall # Z-1448-2012

REASON
Increased risk of intraperitoneal volume (IIPV), referred to as Overfill.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by letter dated March 30, 2012, and April 3, 2012.
Manufacturer: Fresenius USA, Inc., Walnut Creek, CA. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
10,146 units

DISTRIBUTION
Nationwide

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About the author

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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