BEUDAMED
    FDA Enforcement Class I Terminated

    T:slim Insulin Delivery System Insulin Infusion Pump

    Recall: Z-0827-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0827-2014
    Event ID
    67264
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tandem Diabetes Care Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 19, 2014
    Initiation Date
    January 10, 2014
    Classification Date
    February 10, 2014
    Termination Date
    September 23, 2014
    Address
    11045 Roselle St Ste 200, N/A, San Diego, CA, 92121-1231, United States

    Description

    T:slim Insulin Delivery System Insulin Infusion Pump

    Reason

    Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

    Code Info

    Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120.

    Distribution

    USA (nationwide)

    Quantity

    12, 807 boxes (10packs)