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Terminated

Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816

FDA Recall Z-0149-2008 · Posted 2007-12-28

Recalling FirmRita Medical Systems, Inc.
Recall StatusTerminated
Product CodeLJT
Date Initiated2007-10-03
Date Terminated2008-07-14
Product Quantity150 kits

Reason for Recall

Incorrect Size Catheter: The product may contain an incorrect size catheter.

Firm 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).

Root Cause

Employee error

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010189VORTEX ACCESS SYSTEMHorizon Medical Products, Inc. · 2001-02-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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