BEUDAMED
    FDA Enforcement Class II Terminated

    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

    Recall: Z-0989-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0989-2017
    Event ID
    76102
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    HEALTH ROBOTICS S.R.L.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2017
    Initiation Date
    November 23, 2016
    Classification Date
    January 10, 2017
    Termination Date
    March 15, 2017
    Address
    Via Sebastian Altmann 9 A, 39100, Bolzano, N/A, Italy

    Description

    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

    Reason

    The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.

    Code Info

    All serial numbers are affected.

    Distribution

    Shipped throughout United States.

    Quantity

    121 systems