BEUDAMED
    FDA Recall Terminated

    Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.

    Recall: Z-1279-03 · Initiated August 25, 2003

    Recall

    Recall Number
    Z-1279-03
    Event Number
    27058
    Firm
    Bausch & Lomb Incorporated
    FEI Number
    1000305478
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 25, 2003
    Posted
    October 15, 2003
    Terminated
    December 15, 2003
    Address
    1501 Graves Mill Road, Lynchburg, VA, 24502

    Description

    Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.

    Reason

    The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.

    Action

    Firm notified customers by phone and letter 8/25/2003 and advised of needle mix-up. Customers were requested to quarantine affected product and return product with response form.

    Distribution

    Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.

    Quantity

    22 boxes