Retiro De Equipo (Recall) de NAMIC Custom Angiographic Kit

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 Navilyst Medical.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Cardiopulmonary Bypass Oxygenator - Product Code DTZ
  • Causa
    Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.
  • Acción
    On 8/12/08, Navilyst Medical sent a fax and phoned the sole domestic hospital account that had received the affected units. Navilyst Medical instructed the consignee to immediately locate, segregate, and quarantine the units. The hospital consignee confirmed that all units were still in their control and that they will maintain them in quarantine awaiting return to Navilyst Medical. The sole international account, Boston Scientific in Ireland was notified of the problem on 8/06/08. This was followed up with an Urgent Medical Device Recall Letter and Verification Form sent via FedEx on 8/20/08.


  • Modelo / Serial
    UPN/Material #H749601902540, and Lot/Batch # 1280052 (domestic product), Lot/Batch #s and 1275834, 1276658, and 1278843 (foreign)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution --- USA including state of MO and country of Ireland.
  • Descripción del producto
    NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. || Angiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.
  • Manufacturer


  • Dirección del fabricante
    Navilyst Medical, 10 Glens Falls Tech Park, Glens Falls NY 12801
  • Empresa matriz del fabricante (2017)
  • Source