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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius LIBERTY Cycler Sets 05087216, Automated Peritoneal Dialysis System lntegrated Cycler Set

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  Class 2 Device Recall Fresenius LIBERTY Cycler Sets 05087216, Automated Peritoneal Dialysis System lntegrated Cycler Set see related information
Date Initiated by Firm September 03, 2010
Date Posted October 20, 2010
Recall Status1 Completed
Recall Number Z-0105-2011
Recall Event ID 56675
510(K)Number K043363  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product 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 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
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact Kathleen Storro
800-662-1237
Manufacturer Reason
for Recall
Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 5799 units
Distribution Nationwide Distribution: Throughout USA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FKX and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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