Events

Retiro De Equipo (Recall) de Device Recall ARGENT SURGICAL SYSTEMSBIOPSY Punches

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Clorox Healthcare Holdings, LLC (dba HealthLink).

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64888
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1656-2013
  • Fecha de inicio del evento
    2013-03-18
  • Fecha de publicación del evento
    2013-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118319
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Punch, surgical - Product Code LRY
  • Causa
    Due to lack of sterilization.
  • Acción
    On March 19, 2013, HealthLink sent their customers letters instructing them to do the following: 1) Screen their inventory and quarantine the product. 2) Notify all customers that received the affected products and ask them to return the lots to their firm. 3) Complete the attached form and return the lots to HealthLink Distribution center. For further assistance, customers were directed to call customer service at 1-800-638-2625.

Device

Device Recall ARGENT SURGICAL SYSTEMSBIOPSY Punches
  • Modelo / Serial
    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.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** || Disposable manual instrument for skin biopsy.
  • Manufacturer
    Clorox Healthcare Holdings, LLC (dba HealthLink)

Manufacturer

Clorox Healthcare Holdings, LLC (dba HealthLink)
  • Dirección del fabricante
    Clorox Healthcare Holdings, LLC (dba HealthLink), 3611 Saint Johns Bluff Rd S Ste 1, Suite 1, Jacksonville FL 32224-2679
  • Empresa matriz del fabricante (2017)
    The Clorox Company
  • Source
    USFDA