BEUDAMED
    FDA Recall Terminated

    Laborie Transducer Cartridge with Luer Lock Reference: DIS130

    Recall: Z-0229-2007 · Initiated October 4, 2006

    Recall

    Recall Number
    Z-0229-2007
    Event Number
    36743
    Firm
    Laborie Medical Technologies
    FEI Number
    1526863
    Product Code
    FEN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 4, 2006
    Posted
    December 1, 2006
    Terminated
    May 18, 2007
    Address
    400 Ave. D, Suite 10, Williston, VT, 05495

    Description

    Laborie Transducer Cartridge with Luer Lock Reference: DIS130

    Reason

    Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041

    Action

    Laborie Medical telephoned Customers on 10/4-5/06 and advised they were sent product DIS130 with Lot # 36G20M41 and or #36H03M005 were incorrectly labeled with expiration date and lacked lot number on the pouch label. Directions were provided for product return.

    Distribution

    Worldwide-USA including states of AR, CA, FL, KY, MA, NY, OK, TX and Country of Canada: Laborie Medical Montreal, Canada Laborie Medical Toronto, Canada

    Quantity

    2,625 units