LIBERTY Automated Peritoneal Dialysis System lntegrated… recallZ-0105-2011 · Fresenius Medical Care Holdings, Inc. · initiated Sep 3, 2010
Terminated All recalls posted in October 2010
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
Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.
Recall details
- Recall number
- Z-0105-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 3, 2010
- Posted by the FDA
- Oct 20, 2010
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 5799 units
- Product code
- FKX
- FDA submissions
- K043363
- Distribution
- Nationwide Distribution: Throughout USA.
Product description
LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.
Code information (models, lots, serial numbers)
Lot Number Expiration Date 09ER08101 05/31/2012 09HR08002 06/30/2012 09HR08003 06/30/2012 09JR08057 07/31/2012 09JR08058 07/31/2012 09JR08059 07/31/2012 09KR08002 08/31/2012 09KR08003 08/31/2012 09KR08004 08/31/2012 09KR08005 08/31/2012 09LR08004 09/30/2012 09LR08005 09/30/2012 09LR08006 09/30/2012 09LR08007 09/30/2012 09LR08008 09/30/2012 09LR08010 09/30/2012 09LR08105 09/30/2012
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
Other products in the same recall event
The FDA groups related products into one recall event (event 56675).
- Z-0103-2011 · TerminatedLIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA …
- Z-0104-2011 · TerminatedLIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham M…
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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