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U.S. Department of Health and Human Services

Class 2 Device Recall Vortex VX

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 Class 2 Device Recall Vortex VXsee related information
Date Initiated by FirmOctober 03, 2007
Date PostedDecember 28, 2007
Recall Status1 Terminated 3 on July 14, 2008
Recall NumberZ-0149-2008
Recall Event ID 45404
510(K)NumberK010189 
Product Classification Vascular System Port Kit - Product Code LJT
ProductVortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
Code Information Lot #: 30938
FEI Number 3017892510
Recalling Firm/
Manufacturer		 Rita Medical Systems, Inc.
1 Horizon Way
Manchester GA 31816-1749
For Additional Information ContactDavid 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		Employee error
ActionNotification 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 Commerce150 kits
DistributionWorldwide : 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 CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LJT
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