BEUDAMED
    FDA Recall Terminated

    HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each box). Sale Agency HAENG LIM SEO WON #45-9, Gunjang-ri, Ganam-myeon, Yeoju-gun, Kyungki-do, Korea

    Recall: Z-0566-2008 · Initiated November 28, 2007

    Recall

    Recall Number
    Z-0566-2008
    Event Number
    45904
    Firm
    Marknew Products
    FEI Number
    1000306539
    Product Code
    MQX
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    November 28, 2007
    Posted
    January 4, 2008
    Terminated
    January 18, 2012
    Address
    9401 Norwalk Blvd, Santa Fe Springs, CA, 90670-2927

    Description

    HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each box). Sale Agency HAENG LIM SEO WON #45-9, Gunjang-ri, Ganam-myeon, Yeoju-gun, Kyungki-do, Korea

    Reason

    Marketed without 510(k)

    Action

    Marknew Products, LLC, sent an Important Recall Notice to their customers on November 27, 2007, advising them that all Haeng Lim Seo Won Acupuncture Needles that they have received, have not been cleared for distribution in the USA. All customers have been requested to return product back to Marknew Products for credit. A response form was included. If customers have questions concerning this product, they are asked to call 562-908-5000.

    Distribution

    Nationwide Distribution

    Quantity

    320-380 boxes/100 packages (10 needles/package)