Fresenius Liberty Cycler-Peritoneal Dialysis Cycler recallZ-0693-2016 · Fresenius Medical Care Renal Therapies Group, LLC · initiated Dec 15, 2015
Class II Terminated All recalls posted in January 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Renal Therapies Group, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0693-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 15, 2015
- Posted by the FDA
- Jan 27, 2016
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 14,094 units
- Product code
- FKX
- FDA submissions
- K043363, K123630
- Distribution
- Nationwide Distribution
Product description
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Code information (models, lots, serial numbers)
All lot numbers
Other devices under the same FDA submission
3 devices cleared under K043363, K123630 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Liberty® 050-87216Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY16 deaths9,148 reports
- Liberty® 050-87212Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY12 deaths2,169 reports
- Liberty® 050-87215Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 death279 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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