BEUDAMED
    FDA Recall Terminated

    ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.

    Recall: Z-0057-2008 · Initiated March 27, 2007

    Recall

    Recall Number
    Z-0057-2008
    Event Number
    44933
    Firm
    I-Flow Corporation
    FEI Number
    3011270181
    Product Code
    MED
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 27, 2007
    Posted
    October 6, 2007
    Terminated
    October 7, 2009
    Address
    20202 Windrow Dr, Lake Forest, CA, 92630-8152

    Description

    ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.

    Reason

    Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.

    Action

    An Important Recall Notification Letter was faxed to affected customers on March 27, 2007. Affected customers were notified of the recall, the reason for recall, and instructed to immediately quarantine any remaining inventory. A Customer Response (and Fax back) form was included with the Recall Notification. Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. Replacement product will be sent out as applicable.

    Distribution

    Worldwide, USA and Australia

    Quantity

    2,587 units