Events

Retiro De Equipo (Recall) de Device Recall Introes Pocket Bougie

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 Brathwaites Oliver 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
    75148
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0067-2017
  • Fecha de inicio del evento
    2016-08-19
  • 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=149464
  • 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
    Stylet, tracheal tube - Product Code BSR
  • Causa
    The introes pocket bougie an endotracheal tube introducer size 14 fr (4.7mm) x 60 cm may break during intubation.
  • Acción
    On August 19, 2016 the firm sent a MEDICAL DEVICE RECALL NOTICE & CORRECTIVE ACTION letter to affected customers. The letter described the reason for the recall and necessary actions to be taken by the consignees. These included: BOMImed is requesting bougies with lot# 101615 to be returned for evaluation due a potential manufacturing concern. Complete the included Medical Device Recall Customer Letter and follow the instructions to obtain a Return Material Authorization number and applicable shipping instructions to return the affected products. BOMImed Regulatory department also requires the below Customer Confirmation section to be completed and return to regulatory@bomimed.com to confirm this notification was received.

Device

Device Recall Introes Pocket Bougie
  • Modelo / Serial
    Model OL-E12102, lot# 101615.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT and NC.*** Foreign Consignee: Canada.
  • Descripción del producto
    The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
  • Manufacturer
    Brathwaites Oliver Medical

Manufacturer

Brathwaites Oliver Medical
  • Dirección del fabricante
    Brathwaites Oliver Medical, 96 Terracon Place, Winnipeg Canada Manitoba
  • Source
    USFDA