Z-0693-2016Class II

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

Name: Z-0693-2016 Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2015-12-15
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2015-12-15 / Terminated / root cause: design

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111 on 2015-12-15. FDA classified it as Class II and gives the reason as "The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or...". 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-0693-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Posted: 2016-01-27
Terminated: 2019-10-07
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius Medical Care issued on December 15, 2015, a n Important Product Notification to all affected customers informing them of the problem and how to recognize the proper latch closing. Questions regarding the contents of the Customer Notification or questions regarding the issue, contact Technical Services at 1-800-227-2572 and reference the Field Action Number FA-2015-10-W. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy.
Quantity in commerce: 14,094 units
Distribution: Nationwide Distribution
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0693-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0693-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-03	2016-01-27

Product code FKX

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)