BEUDAMED
    FDA Recall Terminated

    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.

    Recall: Z-2180-2012 · Initiated June 15, 2012

    Recall

    Recall Number
    Z-2180-2012
    Event Number
    62341
    Firm
    Angiodynamics Worldwide Headquarters
    FEI Number
    3008319439
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 15, 2012
    Posted
    August 9, 2012
    Terminated
    February 10, 2016
    Address
    14 Plaza Dr, Latham, NY, 12110-2166

    Description

    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.

    Reason

    AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.

    Action

    The firm, AngioDynamics, Inc., sent an "Urgent Medical Device Recall - Immediate Action Required letter dated June 15, 2012 to all consignees/customers via FedEx. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to carefully read this recall notification in its entirety; IMMEDIATELY DISCONTINUE USE OF AND SEGREGATE RECALLED PRODUCT in a secure location for return to AngioDynamics, Inc.; immediately remove recalled product from their inventory; immediately forward a copy of this recall notification to all sites to which they have distributed affected product; and promptly complete, sign and return the Reply Verification Tracking Form (even if you do not have any product to return) via fax to Soft-Vu Angiographic Catheter Recall Coordinator at 1-518-798-1360 or email [email protected]. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday: Eastern Standard Time) to obtain a replacement. The consignees/customers were also instructed to package and return the recalled product, write the RMA number on the box and send to AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804; Attn: Soft-Vu Angiographic Catheter Recall Coordinator. If you have any questions about this recall action, contact your local Sales Representative or AngioDynamics, Inc. Customer Service Manager at 800-772-6446 or by email at [email protected]

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.

    Quantity

    7 boxes/35 units