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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius LIBERTY 05087215 Automated Peritoneal Dialysis System Line Cycler Set

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  Class 2 Device Recall Fresenius LIBERTY 05087215 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-0104-2011
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 (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.
Code Information Lot Number Expiration Date 09CR08086 03/31/2012 09DR08038 04/30/2012 09JR08092 07/31/2012 09JR08093 07/31/2012 09KR08061 08/31/2012 
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 1524 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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