Fresenius Liberty Cycler recallZ-0148-2014 · Fresenius Medical Care Holdings, Inc. · initiated Oct 14, 2013
Class II Terminated All recalls posted in November 2013
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 Holdings, Inc. 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
Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
FDA root cause category: Device Design
What the company is doing
Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.
Recall details
- Recall number
- Z-0148-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 14, 2013
- Posted by the FDA
- Nov 5, 2013
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 16,600
- Product code
- FKX
- FDA submissions
- K043363
- Distribution
- USA Nationwide Distribution
Product description
Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
Code information (models, lots, serial numbers)
All serial numbers
Other devices under the same FDA submission
3 devices cleared under K043363 — 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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