BEUDAMED
    FDA Recall Open, Classified

    IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

    Recall: Z-2267-2024 · Initiated May 21, 2024

    Recall

    Recall Number
    Z-2267-2024
    Event Number
    94773
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    PCT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 21, 2024
    Posted
    July 3, 2024
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    Description

    IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

    Reason

    A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).

    Action

    On May 21, 2024 URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: IMMEDIATELY: 1. Stop using the product subject to recall. 2. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). 3. Segregate this product in a secure location for return to AngioDynamics, Inc. 4. Forward a copy of this recall notification to all sites to which you have distributed affected product.

    Distribution

    US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.

    Quantity

    1,500 units (75 kits with 20 units per kit)