Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incor
FDA device recall Z-0149-2008 · posted 2007-12-28 · Terminated
Recall details
- Recalling firm
- Rita Medical Systems, Inc.
- Reason for recall
- Incorrect Size Catheter: The product may contain an incorrect size catheter.
- 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).
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 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.
- Date initiated
- 2007-10-03
- Date posted
- 2007-12-28
- Date terminated
- 2008-07-14
- Location
- Manchester, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VORTEX ACCESS SYSTEM (K010189) | Horizon Medical Products, Inc. | 2001-02-12 |