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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
Brand
Rita Medical Systems, Inc.
Lot Codes / Batch Numbers
Lot #: 30938
Products Sold
Lot #: 30938
Rita Medical Systems, Inc. is recalling Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile due to Incorrect Size Catheter: The product may contain an incorrect size catheter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Size Catheter: The product may contain an incorrect size catheter.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, CO, FL, GA, MD, NC, OH, TX, VT
Page updated: Jan 10, 2026