Recall Z-0149-2008 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Rita Medical Systems, Inc.
Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
| Date | Dec 28, 2007 (initiated Oct 3, 2007) |
| Status | Terminated |
| Reason | Incorrect Size Catheter: The product may contain an incorrect size catheter. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010189 | VORTEX ACCESS SYSTEM Horizon Medical Products, Inc., Feb 12, 2001 |