Class 2 Device Recall BENEPHIT CV Infusion System

• Date Initiated by Firm: February 06, 2012
• Date Posted: February 28, 2012
• Recall Status: Terminated on February 10, 2016
• Recall Number: Z-1113-2012
• Recall Event ID: 61123
• 510(K)Number: K082163
• Product Classification: Catheter, continuous flush - Product Code KRA
• Product: AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.
• Code Information: Lot 550790
• Recalling Firm/ Manufacturer: Angiodynamics Worldwide Headquarters; 14 Plaza Drive; Latham NY 12110-3421
• Manufacturer Reason for Recall: The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Field Safety Notices (FSNs), entitled Urgent - Medical Device Recall, were sent to consignees on 02/06/2012 via USPS certified mail, return receipt requested. The letters identified the affected devices, the issue, hazard involved, and actions to be taken by the customer and AngioDynamics. The FSN directs consignees to identify and segregate the recalled lots, returning any affected product to AngioDynamics, Inc., Queensbury, NY 12804. The Recall Reply Form should be completed and faxed to 518-798-1360. --- If customers have distributed the affected product/lot, they are instructed to inform their customers of this recall action immediately, and then return the recalled units. --- If customers have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please contact the local sales representative or call Julie Blair, Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. Customers may also e-mail questions to customerservice@angiodynamics.com
• Quantity in Commerce: 4 units
• Distribution: Nationwide Distribution -- Florida, Iowa, Maryland, New York, and Texas.
• 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 = KRA