Events

Retiro De Equipo (Recall) de Device Recall Maquet Getinge Group Pediatric Arterial Cannula

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 Maquet 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
    62471
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2210-2012
  • Fecha de inicio del evento
    2012-05-29
  • Fecha de publicación del evento
    2012-08-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110719
  • 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
    Cannula, arterial, cardiopulmonary bypass (cpb), embolism protection - Product Code NCP
  • Causa
    Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
  • Acción
    Maquet issued Urgent Device 2, Recall letters/Urgent Product Recall Forms dated May 29, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their current stock and identify any affected product and remove from their inventory. Customers were instructed to contact the customer service department at 800-777-4222 (option #2, followed by option #2). Customers were also instructed to completed the enclsoed Recall Form to acknowledge receipt of the notification and to document the current status of the devices shipped to their facility. For questions regarding this recall call 973-709-7660.

Device

Device Recall Maquet Getinge Group Pediatric Arterial Cannula
  • Modelo / Serial
    510k023251  US Catalog Number 161412 Batch Number 92048923   Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including MI, MN and Internationally
  • Descripción del producto
    Maquet Getinge Group Pediatric Arterial Cannula || Maquet Cardiopulmonary AG Kehler Strabe 31 || 76437 Rastatt Germany Phone +49 7222 932-0 || Fax: +49 7222 932-1888 || info.cp@maquet.com || www.maquet.com || Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
  • Manufacturer
    Maquet Inc.

Manufacturer

Maquet Inc.
  • Dirección del fabricante
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA