Class 2 Device Recall DuraMax

• Date Initiated by Firm: December 30, 2011
• Date Posted: January 12, 2012
• Recall Status: Terminated on February 10, 2016
• Recall Number: Z-0721-2012
• Recall Event ID: 60804
• 510(K)Number: K101843
• Product Classification: Catheter, hemodialysis, implanted - Product Code MSD
• Product: Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302804 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY USA 12804 Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis.
• Code Information: FG Lot Numbers: 541558, 542262, 542266, 543822, 543823, 556670, 556672, C40503
• Recalling Firm/ Manufacturer: Angiodynamics Worldwide Headquarters; 14 Plaza Drive; Latham NY 12110-3421
• For Additional Information Contact: David Greer; 518-795-1676
• Manufacturer Reason for Recall: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
• FDA Determined Cause: Nonconforming Material/Component
• Action: AngioDynamics sent an Urgent - Medical Device Recall letter dated December 30, 2011, via certified mail to all affected customers. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to examine inventory, segregate the recalled lots and return remaining inventory to the firm. The letter states that replacement product will be shipped upon receipt and confirmation of the returned product. Customers were advised to complete the Recall Reply Form included and fax to DuraMax Hemodialysis Catheter Recall Coordinator at 518-798-1360. For questions contact your local representative or call the Customer Service Manger at ANGIODYNAMICS Customer Service at 1-800-772-6446.
• Quantity in Commerce: 1336 units
• Distribution: Worldwide Distribution - USA (Nationwide)
• 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 = MSD