Z-0103-2011

LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient...

Name: Z-0103-2011 LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2010-09-03
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2010-09-03 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius... on 2010-09-03. The reason FDA records is "Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0103-2011
Status: Terminated
Initiated: 2010-09-03
Posted: 2010-10-20
Terminated: 2023-02-16
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.
Quantity in commerce: 363,265 units
Distribution: Nationwide Distribution: Throughout USA.
Product codes and lots: Lot Number Expiration Date 09AR08026 1/31/2012 09AR08045 1/31/2012 09AR08046 . 11/30/2011 09AR08092 1/31/2012 09AR08093 1/31/2012 09AR08103 1/31/2012 09AR08104 01/31/2012 09AR08119 11/30/2011 09BR08034 02/29/2012 09BR08035 2/29/2012 09BR08036 02/29/2012 09BR08037 2/29/2012 09BR08038 02/29/2012 09BR08050 2/29/2012 09BR08051 02129/2012 09BR08052 02129/2012 09BR08073 02129/2012 09BR08074 2/29/2012 09BR08801 02/29/2012 09BR08802 02/29/2012 09BR08803 2/29/2012 09CR08018 3/31/2012 09CR08019 3/31/2012 09CR08032 3/31/2012 09CR08033 03/31/2012 09CR08034 3/31/2012 09CR08035 3/31/2012 09CR08095 3/31/2012 09DR08001 4/30/2012 09DR08002 04/30/2012 09DR08023 4/30/2012 09DR08037 4/30/2012 09DR08039 4/30/2012 09DR08040 04130/2012 09ER08093 05131/2012 09ER08094 05131/2012 09ER08095 05131/2012 09ER08096 05131/2012 09ER08097 5/31/2012 09ER08104 05/31/2012 09HR08072 06/30/2012 09HR08073 6/30/2012 09HR08074 06/30/2012 09HR08099 06/30/2012 09HR08100 06/30/2012 09HR08101 6/30/2012 09HR08130 06/30/2012 09HR08131 06/30/2012 09JR08016 07/31/2012 09JR08017 07/31/2012 09JR08018 07/31/2012 09JR08019 7/31/2012 09JR08095 07131/2012 09JR08096 07131/2012 09JR08097 713112012 09JR08106 713112012 09KR08007 813112012

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)