BEUDAMED
    FDA Recall Terminated

    DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic Kit, Catalog Number/REF 10302812, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    Recall: Z-1768-2010 · Initiated January 8, 2010

    Recall

    Recall Number
    Z-1768-2010
    Event Number
    55701
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 8, 2010
    Posted
    June 4, 2010
    Terminated
    July 25, 2012
    Address
    603 Queensbury Avenue, Queensbury, NY, 12804

    Description

    DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic Kit, Catalog Number/REF 10302812, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

    Reason

    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.

    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.

    Distribution

    Nationwide and St. Thomas, VI

    Quantity

    137