Z-0799-2013Class II

Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal...

Name: Z-0799-2013 Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2012-10-12
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2012-10-12 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis on 2012-10-12. FDA classified it as Class II and gives the reason as "There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated 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-0799-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-12
Posted: 2013-02-11
Terminated: 2020-12-30
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
Quantity in commerce: 560 cases, totaling 5590 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot 12BR08009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0799-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0799-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-11

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)