Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part… recallZ-0799-2013 · Fresenius Medical Care Holdings, Inc. · initiated Oct 12, 2012
Class II Terminated All recalls posted in February 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
There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
FDA root cause category: Process control
What the company is doing
Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
Recall details
- Recall number
- Z-0799-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 12, 2012
- Posted by the FDA
- Feb 11, 2013
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 560 cases, totaling 5590 units
- Product code
- FKX
- FDA submissions
- K043363
- Distribution
- Nationwide Distribution.
Product description
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Code information (models, lots, serial numbers)
Lot 12BR08009
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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