BEUDAMED
    FDA Recall Terminated

    Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936

    Recall: Z-0709-03 · Initiated March 5, 2003

    Recall

    Recall Number
    Z-0709-03
    Event Number
    25777
    Firm
    I-Flow Corporation
    FEI Number
    3011270181
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 5, 2003
    Posted
    April 3, 2003
    Terminated
    December 1, 2004
    Address
    20202 Windrow Dr, Lake Forest, CA, 92630

    Description

    Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936

    Reason

    Wrong component may result in over infusion of medications.

    Action

    Recall was initiated by fax on March 5, 2003 and follow-up email on March 6, 2003. Firm is requesting returns of any unused product.

    Distribution

    States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa.

    Quantity

    5,808 units