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U.S. Department of Health and Human Services

Class 2 Device Recall DuraMax Chronic Hemodialysis Catheter

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  Class 2 Device Recall DuraMax Chronic Hemodialysis Catheter see related information
Date Initiated by Firm January 24, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on February 02, 2016
Recall Number Z-0586-2012
Recall Event ID 59833
510(K)Number K080400  K101843  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY USA 12804.

The AngioDynamics DuraMax¿ Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
Code Information Lot C28712
Recalling Firm/
Angiodynamics, Inc.
603 Queensbury Avenue
Queensbury NY 12804
For Additional Information Contact S. Michael Sharp, PhD, FRAPS
Manufacturer Reason
for Recall
AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, AngioDynamics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 28, 2011 and response form via Certified Mail, Return Receipt Requested, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to identify and segregate the recalled lots; complete and return the enclosed DuraMax HemoDialysis Catheter Recall Reply Form via fax to: Attn: DuraMax HemoDialysis Catheter Recall Coordinator at 518-798-1360 (even if they don't have any product); and do not use the affected product, return and ship the recalled product to ANGIODYNAMICS (replacement product will be shipped upon receipt and confirmation of the returned product). If the customers are in immediate need for replacement product, they should fax the completed Recall Reply Form, along with a copy of the product label, to Customer Service at (518) 798-1360 or call us at (800) 772-6446, x1358 or x1363. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call ANGIODYNAMICS customer service at 1-800-772-6446 or email to: customerservice@angiodynamics.com.
Quantity in Commerce 12 units
Distribution Nationwide distribution.
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.