Events

Retiro De Equipo (Recall) de Thayer MiniSpacer Dual Spray MDI Adapter

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 Thayer Medical Corporation.

¿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
    75338
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1146-2017
  • Fecha de publicación del evento
    2017-02-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150065
  • 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
    Nebulizer (direct patient interface) - Product Code CAF
  • Causa
    The insert and case label description of the device incorrectly reads counter incrementing actuator with 22mm o.D./i.D. connections.
  • Acción
    Thayer Medical sent an Urgent Medical Device Recall letter dated September 30, 2016, to all affected customers. The letter informed customers that Thayer Medical has identified a labeling error on REF 1543A, Thayer MiniSpacer Dual Spray MDI Adapter with Counter Incrementing Actuator and 15mm O.D./I.D. Connections. Customers were informed to complete and return the attached Customer Reply Form by email to info@thayermedical.com or fax to 1-520-790-5854. For questions regarding this recall call 520-790-5393, ext 2210.

Device

Thayer MiniSpacer Dual Spray MDI Adapter
  • Modelo / Serial
    160214, 160301, 160901
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. || The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream
  • Manufacturer
    Thayer Medical Corporation

Manufacturer

Thayer Medical Corporation
  • Dirección del fabricante
    Thayer Medical Corporation, 4575 S Palo Verde Rd Ste 337, Tucson AZ 85714-1961
  • Empresa matriz del fabricante (2017)
    Thayer Medical Corporation
  • Source
    USFDA