BEUDAMED
    FDA Recall Terminated

    Continuum MR Compatible Infusion Pump. Pump Model #3009135

    Recall: Z-0841-05 · Initiated March 22, 2005

    Recall

    Recall Number
    Z-0841-05
    Event Number
    31565
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2005
    Posted
    May 13, 2005
    Terminated
    August 17, 2005
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    Continuum MR Compatible Infusion Pump. Pump Model #3009135

    Reason

    Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.

    Action

    The recalling firm issued a Field Correction letter dated 3/9/05 to all their customers. The letter instructed the consignee on how to apply the new warning labels, to discard the old Operation Manual and replace it with the new one.

    Distribution

    The products were shipped nationwide to hospitals and outpatient MRI office. The product was shipped to government facilities in CA, DC, MD, NJ, SC, WA, and WV. The product was also shipped to Austriala, Canada, Mexico, United Arib, Austria, Germany, Denmark, France, Great Britain, Hong Kong, Iceland, Italy, Netherlands, Norway, Portugal, Sweden, and Singapore.

    Quantity

    461 units