BEUDAMED
    FDA Recall Terminated

    Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001

    Recall: Z-1897-2008 · Initiated May 30, 2008

    Recall

    Recall Number
    Z-1897-2008
    Event Number
    48639
    Firm
    Curlin Medical Llc
    FEI Number
    3002936294
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 30, 2008
    Posted
    September 22, 2008
    Terminated
    June 11, 2009
    Address
    15751 Graham St, Huntingtn Bch, CA, 92649-1630

    Description

    Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001

    Reason

    Over-delivery/free-flow in the past eight months involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.

    Action

    On May 30, 2008, Curlin Medical began distribution of a "Voluntary Field Correction Advisory Notice" to all customers in the United States via USPS Registered Mail. The Notice informed customers of the problem and gave the customers (1) Guidelines on testing pump volumetric accuracy, (2) Updated user manuals to elevate the "caution" statement related to dropped pumps to a "warning" statement, and (3) A warning label to be located on the pump: "Warning: Impact may cause damage. If dropped, pump must be checked for accuracy prior to use". A toll free number (888-287-5999) was given for customers experiencing issues that require immediate assistance.

    Distribution

    Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa.

    Quantity

    39,366 units for all affected products/models total