Z-1448-2012

Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis...

Name: Z-1448-2012 Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2012-03-30
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2012-03-30 / Terminated / root cause: software

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius... on 2012-03-30. The reason FDA records is "Increased risk of intraperitoneal volume (IIPV), referred to as Overfill". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1448-2012
Status: Terminated
Initiated: 2012-03-30
Posted: 2012-04-24
Terminated: 2016-08-04
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
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 code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Increased risk of intraperitoneal volume (IIPV), referred to as Overfill
Root cause tag: software
FDA root cause: Software design
Action: Fresenius Medical Care sent a Urgent Product Information letter dated March 30, 2012, and April 3, 2012, to all affected customers. The letter was sent via Certified Mail, Return Receipt Requested. The letter identified the product the problem and the action needed to be taken by the customer. Recall to occur in 2 phases: Phase I: Fresenius Medical Care notified all clinics with patients using Liberty Cyclers with software versions earlier than 2.8 that these patients are receiving updated User Manuals and Handi-Guides. These new materials will include updated descriptions of the safety warnings included with the materials provided with the release of software version 2.8. Clinics will also be informed that their patients will be receiving replacement cyclers with updated software within 12 months. These notifications via telephone and certified letter (return receipt requested). Following clinic notification, Fresenius Medical Care will contact patients operating Liberty Cyclers with software versions earlier than 2.8 by phone, informing them that they will be receiving updated User Manuals and Handi-Guides. In addition, these patients will be informed that they will be receiving replacement cyclers with updated software at some point in the future and that Fresenius Medical Care anticipates that the full timeline of cycler replacements will occur over several months. A certified letter return receipt requested will be sent to all patients after the initial phone contact containing the updated User Manuals and Handi-Guides. Phase II: Liberty Cyclers with updated software will be issued to customers using Liberty Cyclers with software versions earlier than 2.8 as inventory is available. Please complete and return the enclosed Reply Form, indicating receipt and understanding of this communication Further questions please call (1-800) 227-2572.
Quantity in commerce: 10,146 units
Distribution: Worldwide Distribution -- USA (nationwide)
Product codes and lots: Product Codes: Cyclers: 180020, 180111 User Manuals: 480001 Handi-Guides: 480017 All machines operating on software versions earlier than version 2.8.

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)