BEUDAMED
    FDA Recall Terminated

    HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

    Recall: Z-0101-2014 · Initiated July 25, 2013

    Recall

    Recall Number
    Z-0101-2014
    Event Number
    65920
    Firm
    HemoCue AB Kuvettgaten 1 Angelholm Sweden
    FEI Number
    3003044483
    Product Code
    GKR
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 25, 2013
    Posted
    October 29, 2013
    Terminated
    August 11, 2014

    Description

    HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

    Reason

    HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.

    Action

    On 8/13/2013 the firm sent Field Safety Notices to their customers.

    Distribution

    Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan.

    Quantity

    42,330 packages/4 boxes/25 microcuvetes