BEUDAMED
    FDA Recall Terminated

    ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 20 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Inc., 603 Queensbury Avenue, Queensbury, NY 12804

    Recall: Z-3267-2011 · Initiated January 28, 2011

    Recall

    Recall Number
    Z-3267-2011
    Event Number
    59820
    Firm
    Angiodynamics Worldwide Headquarters
    FEI Number
    3008319439
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 28, 2011
    Posted
    September 19, 2011
    Terminated
    October 18, 2012
    Address
    14 Plaza Drive, Latham, NY, 12110-3421

    Description

    ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 20 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Inc., 603 Queensbury Avenue, Queensbury, NY 12804

    Reason

    The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.

    Action

    URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/28/11) and Recall Reply Forms were sent to the consignees via Certified Mail, Return Receipt Requested. The letters identified the scope of the recall, the reason for the recall, the status, and action to be taken. Customers were to identify and segregate the recalled lot in their possession. They were also to complete and fax back the Reply Form. The recalled product should be returned along with a copy of the Reply Form. Replacement product would be shipped upon receipt and confirmation of the returned product. Questions or concerns should be directed towards customers' local sales representative or call Julie Blair, Customer Service Manager at 1-800-772-6446.

    Distribution

    Worldwide Distribution -- USA and The Netherlands.

    Quantity

    24 units