BEUDAMED
    FDA Recall Terminated

    ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE, MANUFACTURED IN USA, AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 Angiographic catheter

    Recall: Z-3259-2011 · Initiated June 7, 2011

    Recall

    Recall Number
    Z-3259-2011
    Event Number
    59794
    Firm
    Angiodynamics Worldwide Headquarters
    FEI Number
    3008319439
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 7, 2011
    Posted
    September 16, 2011
    Terminated
    October 18, 2012
    Address
    14 Plaza Drive, Latham, NY, 12110-3421

    Description

    ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE, MANUFACTURED IN USA, AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 Angiographic catheter

    Reason

    The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length.

    Action

    The firm ANGIODYNAMICS, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2011 to the consignees via Certified Mail, Return Receipt Requested. The letter described the product, problem and action to be taken. The customers were instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. The letter also instructed the consignees to (1.) Identify and segregate the recalled lot that is in your possession, (2.) Complete the enclosed Soft-Vu Angiographic Catheter Recall Reply Form and fax it to the attention of the Soft-Vu Angiographic Catheter Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to ANGIODYNAMICS. (3.) Ship the recalled product to ANGIODYNAMICS. Replacement product will be shipped upon receipt and confirmation of the returned product. Reference Return Authorization Number XXXXXXXXXX on the outside of the shipping box and include a copy of the Soft-Vu Angiographic Catheter Recall Reply Form with your shipment. 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 the Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. You may also e-mail your questions to [email protected].

    Distribution

    Worldwide distribution: USA (nationwide) including states of: California, Tennessee, and Wisconsin, and country of: Spain.

    Quantity

    Domestic - 25 units; Foreign - 5 units