Retiro De Equipo (Recall) de Device Recall Chemetron

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 Allied Healthcare Products 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 2
  • 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
    compressed gas cylinder and valve - Product Code ECX
  • Causa
    Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
  • Acción
    The recalling firm first notified their customers via a letter dated 5/15/09 issued regular mail explaining the reason for recall and requesting the cylinders with specific post valves be returned. A second letter dated 6/1/09 was issued via regular mail which provided specific shipping dates that each customer received the suspect product. Neither of these two letters requested subrecall. A third letter dated 6/17/09, which included copies of the first two letters, via certified mail. This letter informed the customer the recall was to be conducted to the user level and requested their customer conduct a subrecall. Requested to remove the cylinder from service and call Allied Healthcare Products for return and a replacement at 1-800-268-1661.


  • Modelo / Serial
    InterMed 08-05-3B and InterMed 09-01-1B located on the post valve.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Class II Recall Worldwide Distribution including states of NY, NC, KY, PA, WI, NH, NJ, CA, CT, FL and Singapore.
  • Descripción del producto
    First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
  • Manufacturer


  • Dirección del fabricante
    Allied Healthcare Products Inc, 1720 Sublette Ave, St. Louis MO 63110
  • Empresa matriz del fabricante (2017)
  • Source