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U.S. Department of Health and Human Services

Class 2 Device Recall Vortex VX

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 Class 2 Recall
Vortex VX
see related information
Date Posted December 28, 2007
Recall Status1 Terminated on July 14, 2008
Recall Number Z-0149-2008
Recall Event ID 45404
Premarket Notification
510(K) Number
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
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/
Rita Medical Systems, Inc.
1 Horizon Way
Manchester, Georgia 31816-1749
For Additional Information Contact David Derrick
706-846-3126 Ext. 3114
Manufacturer Reason
for Recall
Incorrect Size Catheter: The product may contain an incorrect size catheter.
FDA Determined
Cause 2
TRAINING: Employee Error
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.
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 = LJT and Original Applicant = HORIZON MEDICAL PRODUCTS, INC.