Events

Retiro De Equipo (Recall) de KC 036, KC 060, KC 072 Cuffed Ventilator Tubing

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 Instrumentation Industries 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
    72396
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0269-2016
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140927
  • 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
    Tube, tracheostomy (w/wo connector) - Product Code BTO
  • Causa
    As a distributor of tubing manufactured by smooth bore plastics, we are initiating a product recall for specific lots of kc 036, kc 060 and kc 072 reusable ventilator tubes due to a possible manufacturing defect: a few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage.
  • Acción
    Instrumentation Industries notified consignees by e-mail and telephone of the recall. The firm also sent a Notice of Product Recall letter dated September 23, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to determine if they have any of the affected product and contact the firm to make arrangements for return to Instrumentation Industries, Inc. Replacement product will be sent as soon as possible after all quality inspections have been completed. If product was further distributed consignees were asked to provide recall information to their customers. Customers with questions should call 412-854-1133, ext 433.

Device

KC 036, KC 060, KC 072 Cuffed Ventilator Tubing
  • Modelo / Serial
    Model Length Lot Numbers KC 036 36 tube P0614015, P0818215, P0825515  KC 060 60 tube P0511915, P0608315 KC 072 72 tube P0618415, P0818515
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
  • Descripción del producto
    Ventilator Tubing
  • Manufacturer
    Instrumentation Industries Inc

Manufacturer

Instrumentation Industries Inc