Retiro De Equipo (Recall) de Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.

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 Vapotherm, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
  • Causa
    A medical device firm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners.
  • Acción
    Vapotherm, Inc. reportedly notified distributors and institutional end users via subscriber list-serve with newsletters sent on 10/13/05, 10/31/05 and 11/04/05. The notifications addressed the CDC epidemiological study, in which no definitive information on the source of the organism was identified. The notice states that the firm continued to recommend disinfection between patients and adherence to FDA limitations on the re-use of single patient consumables. Subsequently, Vapotherm reported that they had developed an enhanced disinfecting protocol including a recommendation for using higher level disinfectants and the use of sterile water in the system. The notification refers consignees to the company website for infection prevention and control resources updates. On 12/20/05, Vapotherm notified their list-serve subscribers that they were recalling 2000i devices to conduct a high level disinfectant protocol with the devices to be returned to end users with newly revised labeling to include recommendation for sterile water use and device components designed to provide humidification within a closed system. On 12/22/05, Vapotherm notified distributors and healthcare practitioners via certified mail flagged 'Urgent'. The firm's notification was reportedly sent to hospital respiratory and infection control departments and advised that other therapies, such as nasal CPAP and standard oxygen therapies should be considered during the recall. The notification directs users to the firm's website where users may log on and obtain return authorization for shipping back to the recalling firm. A response form is included with the notification and users are requested to fax back for confirmation of notification.


  • Modelo / Serial
    All S/Ns of the Vapotherm" Model 2000i are affected.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Products were sold to medical device distributors and end users nationwide and in international markets.
  • Descripción del producto
    Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.
  • Manufacturer


  • Dirección del fabricante
    Vapotherm, Inc., 198 Log Canoe Circle, Stevensville MD 21666-2128
  • Source