BEUDAMED
    FDA Recall Terminated

    I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742

    Recall: Z-0358-2007 · Initiated November 29, 2006

    Recall

    Recall Number
    Z-0358-2007
    Event Number
    36984
    Firm
    I-Flow Corporation
    FEI Number
    3011270181
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 29, 2006
    Posted
    January 18, 2007
    Terminated
    December 11, 2009
    Address
    20202 Windrow Dr, Lake Forest, CA, 92630-8152

    Description

    I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742

    Reason

    The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.

    Action

    A Recall Notification Letter was faxed to affected customers on November 29, 2006. Affected customers were notified of the identity of product subject to recall, the reason for recall, and instructed to quarantine immediately any remaining inventory. A Customer Response (FAX back) form was included with the Recall Notification Letter (dated November 29, 2006). Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. The fax back form indicates the quantity of remaining product from each lot the customer may have.

    Distribution

    Nationwide

    Quantity

    3475