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U.S. Department of Health and Human Services

Class 2 Device Recall DuraMax

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  Class 2 Device Recall DuraMax see related information
Date Initiated by Firm December 30, 2011
Date Posted January 12, 2012
Recall Status1 Terminated 3 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/
Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham NY 12110-3421
For Additional Information Contact David Greer
Manufacturer Reason
for Recall
The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
FDA Determined
Cause 2
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 and Original Applicant = ANGIODYNAMICS, INC.