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U.S. Department of Health and Human Services

Class 2 Device Recall AMICUS Exchange Kit

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  Class 2 Device Recall AMICUS Exchange Kit see related information
Date Initiated by Firm May 24, 2013
Date Posted June 08, 2013
Recall Status1 Open3, Classified
Recall Number Z-1523-2013
Recall Event ID 65296
510(K)Number K111702  
Product Classification Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
Product AMICUS Exchange Kit;

Product Usage:
This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Code Information Model No.: R4R2339; , Lot No.: FA12C07070; , Expiration Date: 03/2014.
Recalling Firm/
Fenwal Inc
3 Corporate Dr Ste 300
Lake Zurich IL 60047-8930
For Additional Information Contact Mr. John Miller
Manufacturer Reason
for Recall
Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s
FDA Determined
Cause 2
Process change control
Action Fenwal sent an Urgent Product Recall letter dated May 24, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, discontinue the use of this prod.uct, return the affected product to Fenwal, and complete and return the attached reply form. For questions call 1-800-333-6925.
Quantity in Commerce 19 Cases (114 Units)
Distribution USA 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LKN and Original Applicant = FENWAL, INC.