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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 VX see related information
Date Initiated by Firm October 03, 2007
Date Posted December 28, 2007
Recall Status1 Terminated 3 on July 14, 2008
Recall Number Z-0149-2008
Recall Event ID 45404
510(K)Number K010189  
Product Classification Vascular System Port Kit - 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/
Manufacturer		 Rita Medical Systems, Inc.
1 Horizon Way
Manchester GA 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		 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 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) Database 510(K)s with Product Code = LJT and Original Applicant = HORIZON MEDICAL PRODUCTS, INC.
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