Events

Retiro De Equipo (Recall) de Device Recall Oxygen Masks, Elongated

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 ConvaTec, Inc.

¿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
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2228-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • 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=155601
  • 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
    Mask, oxygen - Product Code BYG
  • Causa
    Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. the failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. while the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.

Device

Device Recall Oxygen Masks, Elongated
  • Modelo / Serial
    Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Descripción del producto
    Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
  • Manufacturer
    ConvaTec, Inc

Manufacturer

ConvaTec, Inc
  • Dirección del fabricante
    ConvaTec, Inc, 7900 Triad Center Dr Ste 400, Greensboro NC 27409-9076
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA