Events

Retiro De Equipo (Recall) de Device Recall QuadroxiD oxygenators

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 Cardiovascular Us Sales, Llc.

¿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
    73390
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1371-2016
  • Fecha de inicio del evento
    2016-02-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144020
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Causa
    Maquet cardiopulmonary (mcp) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
  • Acción
    The firm, Maquet Inc., sent an "URGENT MEDICAL DEVICE RECALL" Letter/Response Form dated 2/23/2016 via Fed Ex to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the list to determine if you have the affected products; monitor patients for signs; monitor and treat signs according to your protocols and clinical judgments; support shock symptoms and maintain circulatory and hemodynamics per your facility's protocol and care guidelines, and complete and and return the enclosed Response Form by email to: MCPrecall2016@maquet.com or fax to: 1-973-629-1518 within three (3) business days. For any questions, please contact your Maquet sales and representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2) Monday through Friday, between the hours of 8:00am and 6:00pm EST.

Device

Device Recall QuadroxiD oxygenators
  • Modelo / Serial
    All sizes and membrane types of QUADROX-i oxygenators, QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; BE-HMOD xxxxx, BEQ-HMO xxxxx, BEQ-HMOD xxxxx, BO-VKMO xxxxx, HMO xxxxx, HMOD xxxxx, VKMO xxxxx, X HMO xxxxx U, X HMOD 30000 U, X VKMO xxxxx U, and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating; XVIVO HMO 70100
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    QUADROX-i oxygenators || Custom tubing packs for the oxygenator
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Dirección del fabricante
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA