BEUDAMED
    FDA Recall Terminated

    Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.

    Recall: Z-1445-06 · Initiated March 29, 2006

    Recall

    Recall Number
    Z-1445-06
    Event Number
    35121
    Firm
    Delphi Medical Systems
    FEI Number
    3002794293
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 29, 2006
    Posted
    August 26, 2006
    Terminated
    October 16, 2006
    Address
    5725 Delphi Dr, Troy, MI, 48098-2815

    Description

    Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.

    Reason

    Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.

    Action

    Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.

    Distribution

    Florida, Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and United Kingdom.

    Quantity

    22 US and 147 international.