Events

Retiro De Equipo (Recall) de NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of South Carolina. Pouch Catalog # 60131481; || (2) Covenant Medical Center, Pouch Catalog #60131603; || (3) St. Joseph Hospital, Pouch Catalog #60101041; || (4) Spectrum Health, Pouch Catalog #61020031 || (5) Rush Foundation Hospital, Kit #65185472 ****** || Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** || Each kit is customized to the needs of the particular hospital identified on the product labeling.

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 Boston Scientific Corp.

¿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
    32288
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1393-05
  • Fecha de inicio del evento
    2004-05-05
  • Fecha de publicación del evento
    2005-08-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-08-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39523
  • 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
    Molded handles used in angiographic manifolds may be occluded.
  • Acción
    Letters dated 5/4/2004 to Risk Managers with instructions to return product.

Device

NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of S...
  • Modelo / Serial
    (1) Medical University of SC label: Lot 942414 (2) Covenant label: Lot 939982, 943645;  (3) St. Joseph label: Lot 940424;  (4) Spectrum label: Lot 940054 (5) Rush Foundation label: Lot 945456; 943043
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.
  • Descripción del producto
    NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of South Carolina. Pouch Catalog # 60131481; || (2) Covenant Medical Center, Pouch Catalog #60131603; || (3) St. Joseph Hospital, Pouch Catalog #60101041; || (4) Spectrum Health, Pouch Catalog #61020031 || (5) Rush Foundation Hospital, Kit #65185472 ****** || Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** || Each kit is customized to the needs of the particular hospital identified on the product labeling.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Dirección del fabricante
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA