Events

Retiro De Equipo (Recall) de Device Recall Aortic Arterial Cannula 24 Fr

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 Cardiopulmonary Ag.

¿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
    80076
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2161-2018
  • Fecha de inicio del evento
    2018-05-14
  • 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=164622
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
  • Acción
    Urgent Medical Device Recall letters were distributed beginning 5/14/18. The letters instructed customers to do the following: 1. Read and understand this notification, and disseminate the information provided to all users, or prospective users, of the affected arterial cannulae. 2. Check your arterial cannula inventory and compare with the Getinge part number, article number and lot number provided on Page 1 of this notification. 3. Remove any affected product that are still in your inventory and prepare it for shipment back to Getinge. 4. Call Getinge Customer Support at 1-888-627-8383 (Press Option 2 and then Option 2) for a Return Authorization (RGA) and for shipping information and label. Customer Support will issue a credit for the product return. 5. Complete, sign and promptly return the filled out response form (Page 4 of this notification) either by email to FieldActions@getinge.com or by fax to 1-973-860-1675.

Device

Device Recall Aortic Arterial Cannula 24 Fr
  • Modelo / Serial
    UDI CODE: 04037691239804, Lot Number: 92180017, 92183437 and 92184278
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
  • Manufacturer
    Maquet Cardiopulmonary Ag

Manufacturer

Maquet Cardiopulmonary Ag
  • Dirección del fabricante
    Maquet Cardiopulmonary Ag, Kehler Strasse 31, Rastatt Germany
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA