BEUDAMED
    FDA Enforcement Class II Terminated

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    Recall: Z-1656-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1656-2013
    Event ID
    64888
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clorox Healthcare Holdings, LLC (dba HealthLink)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2013
    Initiation Date
    March 18, 2013
    Classification Date
    July 2, 2013
    Termination Date
    February 25, 2014
    Address
    3611 Saint Johns Bluff Rd S Ste 1, Suite 1, Jacksonville, FL, 32224-2679, United States

    Description

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    Reason

    Due to lack of sterilization.

    Code Info

    1232040, 1232039, 1232038, 1232037, 1232029, 1232027, 1232026, 1232025, 1232023, 1232022, 1232019, 1232018, 1232017, 1232016, 1232014, 1232012, 1232011, 1232008, 1232007, 1232006, 1231322, 1231321, 1231320, 1231315, 1226439, 1226438, 1226434, 1226433, 1226431, 1226430, 1226429, 1226428, 1226427, 1226426, 1226422, 1226420, 1226419, 1226418, 1226417, 1226415, 1226414, 1222301, 1222302, 1222303, 1222304, 1222305, 1222306, 1222307, 1222308, 1222309, 1222310, 1222311, 1222312, 1222313, 1222314, 1222315, 1222316, 1222317, 1222323, 1222324, 1222325, 1222326, 1222327, 1222328, 1222329, 1222330, 1222331, 1222332, 1222333, 1222334, 1222335, 1222336, 1222337, 1222338, 1222339, 1222001, 1217408, 1217407, 1217406, 1217405, 1217403, 1217402, 1217401, 1214505, 1213925, 1213922, 1213920, 1213919, 1213915, 1213914, 1213913, 1213912, 1213911, 1213909, 1213908, 1213904, 1213903, 1213902, 1213901, 1211614, 1211613, 1208728, 1208727, 1208726, 1208725, 1208724, 1208723, 1208722, 1208721, 1208720, 1207323, 1205328, 1205327, 1205326, 1205325, 1205324, 1205323, 1205322, 1205321, 1205320, 1205319, 1205318, 1205317, 1205316, 1205315, 1201925, 1201924, 1201923, 1201922, 1201921, 1201920, 1201919, 1201918, 1201917, 1201916, 1201915, 1201914, 1201913, 1201912, 1201911, 1201910, 1201909, 1200511, 1200319, 1134635, 1134634, 1134633, 1134632, 1134631, 1134630, 1134629, 1134628, 1134627, 1134626, 1134625, 1134624, 1129718, 1129329, 1129326, 1129325, 1129323, 1129322, 1129321, 1129320, 1129319, 1129318, 1129317, 1129316, 1129315, 1129314, 1128318, 1125622, 1125621, 1125620, 1125619, 1125618, 1125617, 1125616, 1125615, 1123516, 1123515, 1123514, 1123010, 1122921, 1122920, 1122919, 1122918, 1122917, 1122916, 1122915, 1122719, 1122718, 1122717, 1122716, 1121520, 1121519, 1121518, 1121517, 1121516, 1121515, 1120814, 1120727, 1120726, 1120725, 1120724, 1120723, 1120722, 1120721, 1120720, 1119923, 1119922, 1119921, 1119920, 1119919, 1119324, 1119323, 1119322, 1119321, 1119320, 1119319, 1118723, 1118722, 1118721, 1118720, 1118719, 1118718, 1118717, 1118716, 1118024, 1118023, 1118022, 1118021, 1118020, 1118019, 1118018, 1118017, 1118016, 1117410, 1117409, 1117408, 1117407, 1116714, 1116713, 1116712, 1116711, 1116710, 1116709, 1116418, 1116018, 1116017, 1116016, 1116015, 1116014, 1116013, 1113217, 1113216, 1112221, 1111807, 1111806, 1111805, 1111804, 1111518, 1111021, 1111020, 1111019, 1111018, 1111017, 1111016, 1110129, 1110128, 1110127, 1110126, 1110125, 1110124, 1110123, 1110122, 1109619, 1109618, 1109616, 1109018, 1109017, 1109016, 1109015, 1109014, 1108315, 1108314, 1108313, 1108312, 1108310, 1108309, 1108025, 1108024, 1108023, 1108022, 1108021, 1108020, 1106226, 1106225, 1105422, 1104210, 1104209, 1104208, 1104207, 1103919, 1102417, 1101819, 1101818, 1101817, 1101816, 1101815, 1100315, 1036135, 1036134, 1036133, 1036132, 1036131, 1036130, 1036129, 1036128, 1036126, 1036125, 1036124, 1036123, 1007711.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.

    Quantity

    772,600 units