BEUDAMED
    FDA Enforcement Class I Terminated

    ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

    Recall: Z-1636-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1636-2016
    Event ID
    72350
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hummingbird Med
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    October 1, 2015
    Classification Date
    May 20, 2016
    Termination Date
    January 26, 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 Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

    Reason

    Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the connection between the "Hummi" Y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.

    Code Info

    Lot 15180, 15286, 15287, 15300, 15305

    Distribution

    Distributed in the states of CA, KY, MD, GA, and IL.

    Quantity

    11500 units