BEUDAMED
    FDA Recall Terminated

    Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065

    Recall: Z-0687-03 · Initiated March 4, 2003

    Recall

    Recall Number
    Z-0687-03
    Event Number
    25779
    Firm
    I-Flow Corporation
    FEI Number
    3011270181
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2003
    Posted
    March 27, 2003
    Terminated
    April 14, 2004
    Address
    20202 Windrow Dr, Lake Forest, CA, 92630

    Description

    Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065

    Reason

    Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.

    Action

    Recall was initiated by Fax on March 4, 2003 and phone calls on March 5, 2003.

    Distribution

    CA, OH, WA, TX, UT, SC, MI, IL.

    Quantity

    2,832 units