Events

Retiro De Equipo (Recall) de Device Recall PreludeSYNC Radial Compression Device

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
    76762
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1766-2017
  • Fecha de inicio del evento
    2017-03-03
  • Fecha de publicación del evento
    2017-04-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154106
  • 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
    Clamp, vascular - Product Code DXC
  • Causa
    Merit medical systems, inc. announces a voluntary field action for the preludesync radial compression device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.
  • Acción
    Merit Medical sent an Urgent Product Recall Notice on March 3, 2017, via letter for consignees to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact Merit Customer Service at (801) 208-4381. For further questions regarding this recall, please call (801) 253-1600.

Device

Device Recall PreludeSYNC Radial Compression Device
  • Modelo / Serial
    Catalog Number: SRB24AC, Lot Numbers: H1068590S1, H1078177, H1078180, H1083628; Catalog Number: SRB24MED, Lot Numbers: H1068587S1,H1073974, H1078179, H1078181, H1083629, H1083630; Catalog Number: SRB29AC, Lot Numbers: H1068591S1, H1078183, H1083631; Catalog Number: SRB29MED, Lot Numbers: H1068589S1, H1078184, H1078185, H1083633.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
  • Descripción del producto
    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Dirección del fabricante
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Empresa matriz del fabricante (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA