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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

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  Class 2 Device Recall Fresenius see related information
Date Initiated by Firm June 03, 2013
Date Posted July 10, 2013
Recall Status1 Terminated 3 on June 18, 2014
Recall Number Z-1674-2013
Recall Event ID 65332
510(K)Number K043363  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Fresenius Liberty Cycler Set Single Conn./Ext DL
Product Number: 050-87216

Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.

Code Information Lot 11PR08083
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		 Cassette may leak during set up or during peritoneal dialysis treatment
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product.
Quantity in Commerce 5480 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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FKX and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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