BEUDAMED
    FDA Enforcement Class I Terminated

    icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

    Recall: Z-0805-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0805-2019
    Event ID
    81942
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2019
    Initiation Date
    January 3, 2019
    Classification Date
    February 22, 2019
    Termination Date
    May 29, 2024
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

    Reason

    There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

    Code Info

    Lot Number 3757712

    Distribution

    US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.

    Quantity

    2050 units