BEUDAMED
    FDA Recall Terminated

    Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60 mL, FLOW RATE 2mL/Hr, Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) Ltd.

    Recall: Z-0267-2012 · Initiated October 20, 2011

    Recall

    Recall Number
    Z-0267-2012
    Event Number
    60316
    Firm
    Wolf Medical Supply Inc.
    FEI Number
    3007328521
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 20, 2011
    Posted
    November 23, 2011
    Terminated
    April 25, 2012
    Address
    13951 Nw 8th, St Fort Lauderdale, FL, 33325-6251

    Description

    Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60 mL, FLOW RATE 2mL/Hr, Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) Ltd.

    Reason

    Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).

    Action

    On 10/20/2011 Wolf Medical Supply Inc., customers were notified by telephone and email. Product was distributed to end users.

    Distribution

    Nationwide distribution, including Puerto Rico.

    Quantity

    8 cases (192 units)