BEUDAMED
    FDA Recall 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 · Initiated March 11, 2015

    Recall

    Recall Number
    Z-1908-2016
    Event Number
    73461
    Firm
    Hummingbird Med
    FEI Number
    3009382876
    Product Code
    KST
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 11, 2015
    Posted
    July 5, 2016
    Terminated
    February 7, 2017
    Address
    20371 Lake Forest Dr, Ste A6, Lake Forest, CA, 92630-8106

    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.

    Action

    The firm, Hummingbird Med Devices, Inc., sent a "Safety Alert" on March 3, 2015 and Addendum on March 11, 2015, to all affected customers. The notification sent on March 3, 2015, instructed customers that: 1) the Hummi Micro device is not recommended to be used with the Baxter Interlink device with the Hummi Micro draw blood transfer device as the Interlink T Connector septum may be damaged. 2) the use of Nexus Medical Micro-T Split Septum T Connector NMT8046 with all uses of the Hummi Micro Draw Blood Transfer device. The connector has been tested and validated for use in combination with the Ameritus Medical's Hummi Micro-Draw Blood Transfer Device. 3) Distributors of the Hummi Micro Draw Device contact and inform all Hummi Micro-Draw Blood Transfer Device users to recommend change to the Nexus Split Septum Micro-T Connector NMT8046 for all uses with the Hummi Micro Draw device. Inservice materials and training on proper Hummi Micro Draw device blunt cannula insertion into the connector's septum will be provided. 4) Distributors complete the attached form indicating hospitals and date contacted, name, and contact information of responsible person and resulting outcome. and 5) Scan and email the attached form to: [email protected] or fax to: 1-949-583-2775. On March 11, 2015, the firm sent out a second email to their distributor to inform customers again that only the split septum T-Connector recommended for use with the Hummi Micro Draw is the Nexus Micro T split septum T-Connector. The Nexus Micro T-Connector is designed to provide improved insertion force and eliminate potential leaking while providing a microbial barrier when used with the Hummi Micro Draw device. The Hummi Micro device manufactured in 2015 now has improved lubrication on the blunt tube which makes insertion into smaller septum opening of the Mexud Micro T-Connector smooth and easier to accomplish. The firm states in the letter that the distributor will offer

    Distribution

    US Distribution in the state of CA.

    Quantity

    62,400