BEUDAMED
    FDA Enforcement Class I Terminated

    ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.

    Recall: Z-1908-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-1908-2016
    Event ID
    73461
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hummingbird Med
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    March 11, 2015
    Classification Date
    July 5, 2016
    Termination Date
    February 7, 2017
    Address
    20371 Lake Forest Dr Ste A6, N/A, Lake Forest, CA, 92630-8106, United States

    Description

    ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.

    Reason

    Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties.

    Code Info

    Lot Numbers: 20140510 20140513 20140516 20140519 20140603 20140606 20140609 20140612 14299

    Distribution

    US Distribution in the state of CA.

    Quantity

    62,400