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U.S. Department of Health and Human Services

Class 2 Device Recall DURAMAX Hemodialysis Catheters, Stack Tip 36 cm PreCurve Basic Kit

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  Class 2 Device Recall DURAMAX Hemodialysis Catheters, Stack Tip 36 cm PreCurve Basic Kit see related information
Date Initiated by Firm January 08, 2010
Date Posted June 04, 2010
Recall Status1 Terminated 3 on July 25, 2012
Recall Number Z-1771-2010
Recall Event ID 55701
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic Kit, Catalog Number/REF 10302815, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
Code Information Lots 981860, C68450  
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Avenue
Queensbury NY 12804
For Additional Information Contact S. Michael Sharp, PhD, FRAPS
518-798-1215 Ext. 1123
Manufacturer Reason
for Recall		 The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test.
FDA Determined
Cause 2		 Other
Action Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
Quantity in Commerce 26
Distribution Nationwide and St. Thomas, VI
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.
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