FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0149-2008
- Recalling firm
- Rita Medical Systems, Inc.
- Product
- Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
- Status
- Terminated
- Initiated
- 2007-10-03
- Posted
- 2007-12-28
- Terminated
- 2008-07-14
- 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.
- Lot, serial or model codes
- Lot #: 30938
- 510(k) numbers
- ["K010189"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 3017892510
- Firm city
- Manchester
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28