Retiro De Equipo (Recall) de Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.

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
    35358
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1189-06
  • Fecha de inicio del evento
    2006-04-21
  • Fecha de publicación del evento
    2006-07-04
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-03-06
  • Fuente del evento
    USFDA
  • 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
    Vaporizer, Anesthesia, Non-Heated - Product Code CAD
  • Causa
    Southmedic has initiated this recall because their japanese distributor received field reports of leaking vapofils. leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. leakage may also expose patients to low concentrations of volatile anesthetics.
  • Acción
    Recall letters were sent to both US consignees via US Postal Service delivery with signature receipt required on April 21, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Southmedic. U.S. and international consignees were instructed to examine inventory immediately to identify if they have any product on hand, discontinue the distribution of these products and return all affected products to Southmedic. Consignees were also instructed to immediately notify their customers if they have further distributed these products.

Device

  • Modelo / Serial
    Lot numbers : I02156, I07205, I03096, I02286, & I12095
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US in FL & NJ Worldwide in Australia, Belgium, Ecuador, Germany, Japan, Netherlands, Sri Lanka, Taiwan, & United Arab Emerates
  • Descripción del producto
    Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Southmedic Inc, Po Box 1365, Barrie Canada Ontario
  • Source
    USFDA