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.
FDA Recall Z-0105-2011 · Posted 2010-10-20
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeFKX
Date Initiated2010-09-03
Date Terminated2023-02-16
Product Quantity5799 units
Reason for Recall
Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution: Throughout USA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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