BEUDAMED
    FDA Recall Terminated

    GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA***

    Recall: Z-0480-2011 · Initiated August 13, 2010

    Recall

    Recall Number
    Z-0480-2011
    Event Number
    57023
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    KZJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 13, 2010
    Posted
    November 26, 2010
    Terminated
    January 5, 2011
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA***

    Reason

    In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.

    Action

    BD Diagnostic Systems issued an Urgent Product Recall letter dated August 2010 to consignees. Consignees were advised of the defect and were requested to discard product for replacement. Distributors were additionally requested to provide distribution lists of end users for direct BD notification. Accounts were requested to return a response form. BD Customer Service can be contacted at 800 675-0908, and BD Technical Services can be contacted at 800-638-8663.

    Distribution

    Worldwide Distribution: USA and the countries of Australila, Belgium, Canada, India, Mexico, New Zealand. Singapore, and South Korea,

    Quantity

    496 units