Events

Retiro De Equipo (Recall) de Southmedic Oxygen Masks with EtCO2 sampling line part number OM21258, 25 masks per case.

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 Southmedic, 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
    78568
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1288-2018
  • Fecha de inicio del evento
    2017-10-17
  • Fecha de publicación del evento
    2018-01-25
  • 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=159778
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Causa
    Potential for loose or missing co2 diffusers which could result in a non-functioning mask.
  • Acción
    Customers were notified via letter on October 17, 2017. Instructions included checking inventory for affected devices and quarantining any found, complete and return the Voluntary Recall Notification Confirmation Form, and arrange for the return of any affected products. On February 14, 2018, the recall was expanded and customers were notified. Instructions were the same as the original notification, but updated the Part/Lot information. For further questions, please call 1 (800) 463-7146

Device

Southmedic Oxygen Masks with EtCO2 sampling line part number OM21258, 25 masks per case.
  • Modelo / Serial
    Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668);  OK-2125-8 (W37602, W37898, W39852, W40051, W40863);  OK-2125-8SLM (W36957, W39164, W39695, W41454);  OM-2125-14 (W36512, W38338);  OM-2125-14SLM (W35876, W39251, W40873);  OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668);  OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546);  OM-2325-8(W38340);  OP-2125-14 (W37273, W39697);  OP-2125-8 (W37031, W38005, W38190, W39027, W39851);  OP-2125-8SLM (W37901, W38692, W39253, W41447)
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the state of California, and Internationally to Canada and Sweden
  • Descripción del producto
    Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. || Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
  • Manufacturer
    Southmedic, Inc.

Manufacturer

Southmedic, Inc.
  • Dirección del fabricante
    Southmedic, Inc., 50 Alliance Blvd, Barrie Canada
  • Empresa matriz del fabricante (2017)
    Southmedic, Inc.
  • Source
    USFDA