BEUDAMED
    FDA Recall Terminated

    CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.

    Recall: Z-0264-04 · Initiated November 10, 2003

    Recall

    Recall Number
    Z-0264-04
    Event Number
    27714
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HJM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2003
    Posted
    December 24, 2003
    Terminated
    April 5, 2004
    Address
    1400 Goodman St N, Rochester, NY, 14609-3547

    Description

    CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.

    Reason

    The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.

    Action

    The recalling firm issued a recall notification dated 11/13/03 to their direct accounts. The recall notification explains the problem and return the product.

    Distribution

    The product was shipped to hospitals/medical facilities and physicians in AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NH, NY, NC, OH, PA, TN, TX, UT, VA, WA, WI, and WV. Nationwide. The product was also shipped to Puerto Rico, Argentina, Australia, Brazil, Canada, China, Hong, Kong, India, Japan, Korea, Malaysia, Mexico, New Zealand, The Netherlands, Philippines, Singapore, Spain, Taiwan, and Thailand.

    Quantity

    2500 packs