||June 08, 2013
||AMICUS Exchange Kit;
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.
||Model No.: R4R2339;
Lot No.: FA12C07070;
Expiration Date: 03/2014
3 Corporate Dr Ste 300
Lake Zurich, Illinois 60047-8930
|For Additional Information Contact
||Mr. John Miller
|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
||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)
||USA Nationwide Distribution