Events

Retiro De Equipo (Recall) de Device Recall Merit One Step Centesis Drainage Catheter

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 Merit Medical Systems, Inc..

¿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
    57418
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0866-2011
  • Fecha de inicio del evento
    2010-11-17
  • Fecha de publicación del evento
    2011-01-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96167
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    Catheter, irrigation - Product Code gbx
  • Causa
    The catheter's valved hub may fail resulting in an inability to drain fluid.
  • Acción
    Merit Medical Systems, Inc. sent a Product Safety Notice letter dated November 18, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide a copy of the Safety Notice form to their applicable customers. Advise them to immediately stop using the affected product and to discard it. Customers were asked to complete and sign the Safety Notice forms and fax them to 1-801-208-3378 and send the original Safety Notice Form with both signatures via Federal Express 2nd day air to: Customer Service Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095-2416 entirety and faxed them For questions regarding this recall call 801-316-4929 or Customer Service at 801-208-4365.

Device

Device Recall Merit One Step Centesis Drainage Catheter
  • Modelo / Serial
    LOT NO.: F762656, F762657, F775508, F775516, F775524, F775533, F775552. . . . H101842, H101902, H108630, H110628, H110629, H110630, H110631, H113645, H113655, H115407, H115409, H118206 ,H118207, H118208, H118209, H118210, H118211, H121450, H121780, H124502, H124506, H124507, H124508, H124509, H124510, H124511, H134990, H134991, H134992, H134993, H134994, H137477, H139171, H141155, H141162, H144090, H144098, H152489, H161044, H168461, H176238, . . . . . T119693, T121646, T122832,T124548, T130679, T132868, T132953, T133542, T134201, T135053, T137437, T139844, T140413, T140414, T141401, T141403, T141404, T142352, T143776, T146337, T146360, T149794, T150330, T150862, T151354, T153082, T153417, T153437, T153683, T153684, T153987, T154640, T157268, T160213, T162756, T167168, T167454, T167544, T168498, T171102, T171125, T171265, T173628, T173860, T174223, T176638, T176932, T177808, T178914, T179018, T179791, T181437
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, AND WV and the countries of Canada, Finland, Germany, Netherlands, Singapore, Sweden, Switzerland, and the UK
  • Descripción del producto
    Merit One Step Centesis Drainage Catheter || Intended for the percutaneous drainage of fluids
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Dirección del fabricante
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Empresa matriz del fabricante (2017)
    Merit Medical Systems Inc
  • Source
    USFDA