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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Liberty Cycler Set Single Conn. Ext. DL.

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  Class 2 Device Recall Fresenius Liberty Cycler Set Single Conn. Ext. DL. see related information
Date Initiated by Firm October 12, 2012
Date Posted February 11, 2013
Recall Status1 Completed
Recall Number Z-0799-2013
Recall Event ID 64175
510(K)Number K043363  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216.

Acute and chronic peritoneal dialysis.
Code Information Lot 12BR08009
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall
There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
FDA Determined
Cause 2
Process control
Action Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
Quantity in Commerce 560 cases, totaling 5590 units
Distribution Nationwide Distribution.
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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