BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0101-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0101-2014
    Event ID
    65920
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    HemoCue AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    July 25, 2013
    Classification Date
    October 29, 2013
    Termination Date
    August 11, 2014
    Address
    Kuvettgaten 1, N/A, Angelholm, N/A, N/A, Sweden

    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.

    Code Info

    Part Number 111715: Lot numbers1208655, 1208658, 1208659, 1208660, 1208663, 1208664, 1209667, 1209669, 1209670, 1209671, 1209672, 1209674, 1209675, 1209677, 1209678, 1210681, 1210683, 1210685, 1210688, 1211690, 1211691, 1211692, 1211694, 1211696, 1211697, 1211699, 1212701, 1212702, 1212703, 1212705, 1212706, 1301708, 1301710, 1301711, 1301712, 1301715, 1301717, 1301719, 1302721, 1302723, 1302725, 1302726, 1303729, 1303734 & 1304737. Part Number 111717: Lot Numbers: 1208657, 1208661, 1208662, 1208665, 1209666, 1209668, 1209673, 1209676, 1210679, 1210680, 1210682, 1210684, 1210686, 1210689, 1211693, 1211695, 1211698, 1212700, 1212704, 1212707, 1301709, 1301713, 1301714, 1301716, 1301718, 1302720, 1302722, 1302724 & 1304738. Part Number 111722: Lot numbers: 1209672, 1210687, 1212701 & 1303727. Part Number 116101; Lot Numbers: 1303730 & 1303735.

    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