Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
This recall has been terminated (originally issued December 28, 2007).
- Company
- Rita Medical Systems, Inc.
- Recall Initiated
- October 3, 2007
- Posted
- December 28, 2007
- Terminated
- July 14, 2008
- Recall Number
- Z-0149-2008
- Quantity
- 150 kits
- Firm Location
- Manchester, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect Size Catheter: The product may contain an incorrect size catheter.
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.
Lot / Code Info
Lot #: 30938
Root Cause
Employee error
Action Taken
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).
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