BEUDAMED
    FDA Recall Terminated

    AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

    Recall: Z-0073-2022 · Initiated April 24, 2020

    Recall

    Recall Number
    Z-0073-2022
    Event Number
    88679
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    OAB
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    April 24, 2020
    Terminated
    September 20, 2022
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    Description

    AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

    Reason

    Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.

    Action

    On April 24, 2020, the firm distributed recall notifications to their consignees, who were all international (non-US). Customers were advised to stop using the recalled product, remove it from inventory, and segregate in a secure location for return. The firm provided further instructions for the return of the product.

    Distribution

    Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.

    Quantity

    37