Events

Retiro De Equipo (Recall) de Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58

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 Mizuho America, 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
    66561
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0378-2014
  • Fecha de inicio del evento
    2013-10-10
  • Fecha de publicación del evento
    2013-11-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122612
  • 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
    Clip, aneurysm - Product Code HCH
  • Causa
    Specific item numbers form lots 27-j and 29-j of sugita t2 aneurysm clips. mini temporary type, are discolored.
  • Acción
    Mizuho sent a Product Recall Notice dated October 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to verify serial number before opening package and conduct a physical examination of the product for discolored Clips from the affected lots. Customers were also asked to fill out the Confirmation of User Receipt, and return to Misuho America. If customers should find affed clips they were instructed to quarantine them an call Mizuho America Customer Service at 800-699-2547 for return instructions. The Clips will be exchanged at no charge. Customers were also asked to ensure that all appropriate persons within the Hospital have been notified of the Recall Notice. For questions regarding this recall call 510-324-4500, ext 122.

Device

Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58
  • Modelo / Serial
    Product Code 17-001-58; Lot No. 29JY
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 || Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
  • Manufacturer
    Mizuho America, Inc.

Manufacturer

Mizuho America, Inc.
  • Dirección del fabricante
    Mizuho America, Inc., 30057 Ahern Ave, Union City CA 94587-1234
  • Empresa matriz del fabricante (2017)
    Mizuho America Inc.
  • Source
    USFDA