BEUDAMED
    FDA Recall Open, Classified

    IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

    Recall: Z-1391-2025 · Initiated February 4, 2025

    Recall

    Recall Number
    Z-1391-2025
    Event Number
    96192
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    PCT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 4, 2025
    Posted
    March 18, 2025
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    Description

    IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

    Reason

    Product is mislabeled with the incorrect fill volume.

    Action

    On February 4, 2025, URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. ACTIONS TO BE TAKEN BY CONSIGNEES OF THE RECALL NOTIFICATION 1. IMMEDIATELY - Stop using the product subject to recall. - Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to AngioDynamics, Inc. - Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. - Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return), following the directions on this page and the Reply Verification Tracking Form. * Email Reply Verification Tracking Form (preferred): [email protected] * Fax Reply Verification Tracking Form: 1-855-273-0519 (Fax #) Attn: ISO-60 Recall Coordinator - Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 6:00 p.m. EST (Monday Friday) to obtain a replacement or credit for your returned product. - Report any Adverse reactions or quality problems associated with recalled devices to US FDA via MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 3. Package and Return the Recalled Product. - Package any product that is being returned in an appropriate shipping box. - Write the RMA number (provided on the Recall Verification Tracking Form) on the RMA reference sticker and affix the sticker to the outside of the shipping box. - Contact AngioDynamics Inc. by phone or email (above contact) for shipping labels for returning the device. - Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: ISO-60 Recall Coordinator

    Distribution

    US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.

    Quantity

    1,800 units