BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb Millenium Phacoemulsification Needles, Needle Microflow 2.2 30 Degree, REF DP8730, 6 needles per pouch, nonsterile.

    Recall: Z-2050-2008 · Initiated March 26, 2008

    Recall

    Recall Number
    Z-2050-2008
    Event Number
    47422
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    NKX
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 26, 2008
    Posted
    September 16, 2008
    Terminated
    January 21, 2010
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch & Lomb Millenium Phacoemulsification Needles, Needle Microflow 2.2 30 Degree, REF DP8730, 6 needles per pouch, nonsterile.

    Reason

    The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable

    Action

    The recalling firm issued letters dated 3/26/08 through a contracted recall notification company who issued the letters via UPS return receipt. A confirmation form was enclosed which was to be completed and returned. If you have questions, contact Customer Service at 1-800-338-2020.

    Distribution

    Distribution was made nationwide direct to medical facilities, which included some government accounts. Foreign distribution was made to Australia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, England, France, Germany, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon.,The Netherlands, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Thailand, Turkey, and United Arab Emerites.

    Quantity

    Total of all sizes - 4,055/6-needle packages