BEUDAMED
    FDA Recall Open, Classified

    NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

    Recall: Z-1381-2023 · Initiated March 2, 2023

    Recall

    Recall Number
    Z-1381-2023
    Event Number
    91909
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    OAB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 2, 2023
    Posted
    April 12, 2023
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    Description

    NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

    Reason

    Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure

    Action

    AngioDynamics issued Urgent Medical Device Recall Letter on March 2, 2023 via Federal Express. Letter states reason for recall health risk and action to take: 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. ComplFx Reply Verification Tracking Form: Attn: NK Probe 5-Pack Recall Coordinator Fax number 1-855-273-0519 3. Package and Return the Recalled Product. Package any product that is being returned in an appropriate shipping box. Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: NK Probe 5-Pack Recall Coordinator

    Distribution

    US Nationwide Distribution: CA,CO, FL, IA, NY, OH

    Quantity

    10 boxes( 5 probes/box)