Events

Retiro De Equipo (Recall) de Device Recall Hydrophylic guidewire

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
    56161
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2104-2010
  • Fecha de inicio del evento
    2010-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92768
  • 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
    wire, guide, catheter - Product Code DQX
  • Causa
    Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
  • Acción
    The firm, Merit Medical System, Inc., notified the Sales representatives by e-mail on June 28, 2010, and instructed them to contact all of their accounts and to advise them to discontinue use and return any unused products to Merit. A Product Recall Notice was to be completed by each facility under the direction of the rep and all activities were to be completed by July 9, 2010. Questions should be directed to Penny Goldman, Senior Product Manager at 801-208-4198 or Jackie Preece, Manager, Customer Service at 801-208-4365.

Device

Device Recall Hydrophylic guidewire
  • Modelo / Serial
    Lot Number K130761 (3 year expiry), P116003 (1 year expiry)
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, NC, NH, NJ, NY, PA, and SD.
  • Descripción del producto
    Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. || Intended to facilitate the placement of devices during diagnostic and interventional procedures.
  • 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