Z-0148-2014Class II

Fresenius Liberty Cycler Part Number: RTLR180111

Name: Z-0148-2014 Fresenius Liberty Cycler Part Number: RTLR180111
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2013-10-14
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2013-10-14 / Terminated / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal... on 2013-10-14. FDA classified it as Class II and gives the reason as "Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0148-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-14
Posted: 2013-11-05
Terminated: 2021-05-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.
Quantity in commerce: 16,600
Distribution: USA Nationwide Distribution
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0148-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0148-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04

Product code FKX

K043363Class IIFresenius Liberty CyclerFresenius Medical Care North America / cleared 2005-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)