Class 2 Device Recall Vortex VX Port

• Date Initiated by Firm: September 27, 2010
• Date Posted: November 17, 2010
• Recall Status: Terminated on June 21, 2011
• Recall Number: Z-0402-2011
• Recall Event ID: 56876
• 510(K)Number: K010189
• Product Classification: Pump, infusion - Product Code FRN
• Product: Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
• Code Information: Catalogue Number: P530K, P5355K, P5405K, P4455K, P12105K, P12155K, P12305K and P12355.
• Recalling Firm/ Manufacturer: Angiodynamics, INC; 1 Horizon Way; Manchester GA 31816-1749
• For Additional Information Contact: David Derrick; 706-846-3126 Ext. 3114
• Manufacturer Reason for Recall: Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
• FDA Determined Cause: Other
• Action: AngioDynamics issued a Notification of Medical Device Correction letter dated September 27, 2010 to customers. The notification served to make the customer aware of the mislabeling. Customers were instructed not to return the affected products. Customers can contact AngioDynamics at 1 800 772-6446 about this correction.
• Quantity in Commerce: 6000 units (includes all port systems listed)
• Distribution: Nationwide Distribution : Throughout the US.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN