Z-1674-2013Class II

Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis...

Name: Z-1674-2013 Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2013-06-03
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2013-06-03 / Terminated

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and... on 2013-06-03. FDA classified it as Class II and gives the reason as "Cassette may leak during set up or during peritoneal dialysis treatment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1674-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-03
Posted: 2013-07-10
Terminated: 2014-06-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Cassette may leak during set up or during peritoneal dialysis treatment
FDA root cause: Unknown/Undetermined by firm
Action: Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product.
Quantity in commerce: 5480 units
Distribution: Nationwide Distribution
Product codes and lots: Lot 11PR08083

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1674-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1674-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10

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)