| Class 2 Device Recall DURAMAX Hemodialysis Catheters, Stack Tip 28 cm PreCurve Basic Kit, | |
Date Initiated by Firm | January 08, 2010 |
Date Posted | June 04, 2010 |
Recall Status1 |
Terminated 3 on July 25, 2012 |
Recall Number | Z-1769-2010 |
Recall Event ID |
55701 |
Product Classification |
Catheter, hemodialysis, implanted - Product Code MSD
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Product | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog Number/REF 10302813, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 |
Code Information |
Lots 978922, 981849, C68446, C68447, 981969 |
Recalling Firm/ Manufacturer |
Angiodynamics, Inc. 603 Queensbury Avenue Queensbury NY 12804
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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 | 137 |
Distribution | Nationwide and St. Thomas, VI |
Total Product Life Cycle | TPLC Device Report |
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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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