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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 Recall
AMICUS Exchange Kit
see related information
Date Posted June 08, 2013
Recall Status1 Open
Recall Number Z-1523-2013
Recall Event ID 65296
Premarket Notification
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/
Manufacturer
Fenwal Inc
3 Corporate Dr Ste 300
Lake Zurich, Illinois 60047-8930
For Additional Information Contact Mr. John Miller
847-550-2300
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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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 = LKN and Original Applicant = FENWAL, INC.
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