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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Vortex® VX		see related information
Date Posted December 28, 2007
Recall Number Z-0149-2008
Product Vortex® VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
Code Information Lot #: 30938
Recalling Firm/
Manufacturer		 Rita Medical Systems, Inc.
1 Horizon Way
Manchester, Georgia 31816-1749
For Additional Information Contact David Derrick
706-846-3126 Ext. 3114
Reason for
Recall		 Incorrect Size Catheter: The product may contain an incorrect size catheter.
Action Notification of the AngioDynamics, Inc. sales force and the domestic and international distributors began on 10/3/2007. Starting on 10/09/2007, Urgent Medical Device Recall letters were sent to all customers requesting that device useage cease and immediate return begin as well as the completion of a fax back form (number of devices used, number to be returned).
Quantity in Commerce 150 kits
Distribution Worldwide : USA including states of AL, AR, CA, CO, FL, GA, MD, NC, OH, TX, and VT, and countries of Australia, Korea and The Netherlands.
 
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