BEUDAMED
    FDA Recall Terminated

    VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter

    Recall: Z-2237-2019 · Initiated June 10, 2019

    Recall

    Recall Number
    Z-2237-2019
    Event Number
    83051
    Firm
    Santanello Surgical LLC
    FEI Number
    3013555389
    Product Code
    JOL
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    June 10, 2019
    Terminated
    January 13, 2021
    Address
    4664 Hayden Run Rd, Columbus, OH, 43221-5937

    Description

    VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter

    Reason

    Lack of package integrity may compromise sterility

    Action

    Santanello Surgical issued recall letter dated 6/10/19 stating reason for recall, health risk and action to take: immediately examine inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Email [email protected] for return shipment procedures and reimbursement process. Questions call Santanello Surgical at 614-955-1832.

    Distribution

    FL,OK, OH, NY, ME, MN, WI

    Quantity

    98