Class 2 Device Recall Benephit

• Date Initiated by Firm: December 05, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on January 29, 2016
• Recall Number: Z-0509-2012
• Recall Event ID: 60587
• 510(K)Number: K082163
• Product Classification: Catheter, continuous flush - Product Code KRA
• Product: Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 603 Queensbury, NY 12804 USA --- COMMON/USUAL NAME - Continuous flush catheter; CLASSIFICATION NAME: Continuous flush catheter; Device Listing # D069932 Benephit Infusion Systems are intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. The Benephit Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit Infusion Systems are also indicated to facilitate TRT in patients who have demonstrated symptoms of acute kidney injury, and whom arterial catheterization for TRT is feasible.
• Code Information: Lot C23415
• Recalling Firm/ Manufacturer: Angiodynamics Worldwide Headquarters; 14 Plaza Drive; Latham NY 12110-3421
• For Additional Information Contact: David A. Greer; 518-795-1676
• Manufacturer Reason for Recall: The Benephit XT Infusion System may contain hairline cracks in the sheath hub.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Angiodynamics Worldwide Headquarters sent a Urgent Medical Device Recall Letter and Response Forms dated December 2, 2011, to all affected customers via Certified Mail on December 5, 2011. The recall is being extended to the medical user level. Customers will be instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. A Return Authorization number (RA #) will be assigned to each customer in the recall notification letter and a UPS account will be provided for return freight. A reply form was provided with the recall notification letter to be completed by each consignee. ACTIONS TO BE TAKEN BY CUSTOMER / USER: (1.) Identify and segregate the recalled lots that are in your possession. (2.) Complete the enclosed Benephit XT Infusion System Recall Reply Form and fax it to the attention of the Benephit XT Infusion System Recall Coordinator at 518-798-1360. The form lists the catalog number, lot numbers, and quantity our records indicate your facility has received. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to ANGIODYNAMICS. (3.) Ship the recalled product to ANGIODYNAMICS. Replacement product will be shipped upon receipt and confirmation of the returned product. Reference Return Authorization Number on the outside of the shipping box and include a copy of the Benephit Infusion System Recall Reply Form with your shipment. (4.) If you have distributed the affected product/lot, please inform your customers of this recall action immediately, and have them return the recalled units to you. --- Certified Mail will verify delivery to each domestic consignee. Non-respondents will be contacted by telephone or via e-mail. --- Corrective Action: Returned product will be quarantined and final disposition has not been determined at this time. A corrective action has been initiated by AngioDynam
• Quantity in Commerce: 55 units domestically
• Distribution: Nationwide Distribution including the states of New York, Pennsylvania, Virginia, Kentucky, Iowa, Illinois, Missouri, Louisiana, Texas, and Utah.
• 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