BEUDAMED
    FDA Recall Open, Classified

    Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

    Recall: Z-2735-2020 · Initiated June 26, 2020

    Recall

    Recall Number
    Z-2735-2020
    Event Number
    85912
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 26, 2020
    Posted
    August 6, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

    Reason

    Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

    Action

    Consignees are being contacted via direct mailing and email. Consignees are asked to review and complete the Recall Response form indicating understanding of notification. Distributors are asked to forward the notification to parties to whom product has been distributed. Smiths Medical will send out 2 additional notifications by email. Phone calls will be made to non-responders.

    Distribution

    Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago

    Quantity

    17019 units