Fresenius Liberty Cycler Set Single Conn./Ext DL recallZ-1674-2013 · Fresenius Medical Care Holdings, Inc. · initiated Jun 3, 2013
Class II Terminated All recalls posted in July 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
Cassette may leak during set up or during peritoneal dialysis treatment
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product.
Recall details
- Recall number
- Z-1674-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 3, 2013
- Posted by the FDA
- Jul 10, 2013
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 5480 units
- Product code
- FKX
- FDA submissions
- K043363
- Distribution
- Nationwide Distribution
Product description
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
Code information (models, lots, serial numbers)
Lot 11PR08083
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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