Events

Retiro De Equipo (Recall) de Device Recall BOMImed Disposable Fiber Optic Medium Laryngoscope Handle

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 Bomimed.

¿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
    77958
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3238-2017
  • Fecha de inicio del evento
    2017-07-13
  • 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=158329
  • 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
    Laryngoscope, rigid - Product Code CCW
  • Causa
    Potential for intermittent lighting (flickering) during use.
  • Acción
    A letter was sent to all the consignees via mail dated July 13, 2017 informing of the recall due to Length variation of the battery contact inside the handle due to manufacturing/assembly variation may potentially cause an intermittent electrical connection resulting in flickering light. Complete the bottom section and return by email to regulatory@bomimed.com to confirm this notice has been received and understood. Check functionality of the light for each handle by engaging a blade and applying pressure to simulate use. Complete this task prior to use. Contact BOMImed for replacements if intermittent lighting is present. Replacement product orders will be organized in a manner to assist in covering all affected customers needs. Contac: Trina Friesen Quality Assurance & Regulatory Manager Tel: 800-667-6276 ext.234 Fax: 877-435-6984 regulatory@bomimed.com

Device

Device Recall BOMImed Disposable Fiber Optic Medium Laryngoscope Handle
  • Modelo / Serial
    Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    IL. PA. and WA CANADA
  • Descripción del producto
    BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. || The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.
  • Manufacturer
    Bomimed

Manufacturer

Bomimed
  • Dirección del fabricante
    Bomimed, 1-100 Irene St, Winnipeg Canada
  • Empresa matriz del fabricante (2017)
    Bomimed Inc
  • Source
    USFDA