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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius LIBERTY 05087212 Automated Peritoneal Dialysis System Line Cycler Set

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  Class 2 Device Recall Fresenius LIBERTY 05087212 Automated Peritoneal Dialysis System Line Cycler Set see related information
Date Initiated by Firm September 03, 2010
Date Posted October 20, 2010
Recall Status1 Completed
Recall Number Z-0103-2011
Recall Event ID 56675
510(K)Number K043363  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.
Code Information Lot Number Expiration Date 09AR08026 1/31/2012 09AR08045 1/31/2012 09AR08046 . 11/30/2011  09AR08092 1/31/2012 09AR08093 1/31/2012 09AR08103 1/31/2012 09AR08104 01/31/2012 09AR08119 11/30/2011 09BR08034 02/29/2012 09BR08035 2/29/2012 09BR08036 02/29/2012  09BR08037 2/29/2012 09BR08038 02/29/2012  09BR08050 2/29/2012 09BR08051 02129/2012  09BR08052 02129/2012 09BR08073 02129/2012  09BR08074 2/29/2012 09BR08801 02/29/2012  09BR08802 02/29/2012  09BR08803 2/29/2012 09CR08018 3/31/2012 09CR08019 3/31/2012 09CR08032 3/31/2012 09CR08033 03/31/2012   09CR08034 3/31/2012 09CR08035 3/31/2012  09CR08095 3/31/2012  09DR08001 4/30/2012 09DR08002 04/30/2012  09DR08023 4/30/2012 09DR08037 4/30/2012 09DR08039 4/30/2012 09DR08040 04130/2012   09ER08093 05131/2012  09ER08094 05131/2012  09ER08095 05131/2012 09ER08096 05131/2012  09ER08097 5/31/2012 09ER08104 05/31/2012 09HR08072 06/30/2012 09HR08073 6/30/2012 09HR08074 06/30/2012 09HR08099 06/30/2012 09HR08100 06/30/2012 09HR08101 6/30/2012  09HR08130 06/30/2012 09HR08131 06/30/2012 09JR08016 07/31/2012 09JR08017 07/31/2012 09JR08018 07/31/2012 09JR08019 7/31/2012 09JR08095 07131/2012 09JR08096 07131/2012 09JR08097 713112012  09JR08106 713112012 09KR08007 813112012             
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 363,265 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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