BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.

    Recall: Z-0765-2007 · Initiated February 9, 2007

    Recall

    Recall Number
    Z-0765-2007
    Event Number
    37281
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HQE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2007
    Posted
    April 21, 2007
    Terminated
    April 7, 2009
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.

    Reason

    The cutter probe tip breaks during use.

    Action

    On 2/12/07, express mail letters were addressed to operating room supervisors to notify them of the recall. Additional E-mail notifications were issued on 2/14/07 to doctors and letters were addressed to them on 2/20/07 to make them aware of the recall, although they do not directly receive the product. The communications instructed them to not use the affected product and to return it, along with the business reply card.

    Distribution

    Class II Recall - Worldwide Distribution --- USA including states of MO, NC, FL, CA, and TX and countries of Canada, China, Japan, Australia, Hong Kong, India, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands

    Quantity

    32,190 units of Catalog No: CX 5825