Events

Retiro De Equipo (Recall) de Device Recall SJM Peel Away Introducer

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 St. Jude 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
    Recall
  • ID del evento
    52457
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1714-2009
  • Fecha de inicio del evento
    2009-06-24
  • Fecha de publicación del evento
    2009-08-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83082
  • 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
    Wire, guide, catheter - Product Code DQX
  • Causa
    St. jude medical has initiated a voluntary recall of two lots of peel away introducers . isolated lots could contain some items that have been mis-labelled with the incorrect french size of the outer box label. some 9f products have been labelled as 7f and vice versa. only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product.
  • Acción
    The Consignee was provided with a St. Jude Medical "Urgent Product Information" letter and a doctor Acknowledgement form, via e-mail on June 2009. The letter described the problem and the product involved and advised to isolate and discontinue use of the product involved. The Consignee will notify the end user and remove any remaining affected units and will notify St Jude Medical of the results.

Device

Device Recall SJM Peel Away Introducer
  • Modelo / Serial
    Lot Number: 2694252.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    OUS only: Belgium.
  • Descripción del producto
    SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO, Rx only. || Intended for use for the introduction of catheters into a vessel.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Dirección del fabricante
    St. Jude Medical, 14901 DeVeau Place, Minnetonka MN 55345
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA