Retiro De Equipo (Recall) de CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare Pty Ltd.

¿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
    RC-2013-RN-00536-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-06
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Baxter is providing additional information regarding correct device use and additional warnings to end users. the improper use of peritoneal dialysis (pd) transfer sets could result in contamination leading to infection or peritonitis. there is also the potential of thyroid dysfunction following iodine exposure in children and infants. the current ifu does not list this as a warning.
  • Acción
    Baxter is providing additional information regarding correct device use and additional warnings to end users. This action has been closed-out on 01/02/2016.

Device

  • Modelo / Serial
    CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long)CAPD Solution Transfer Set with Locking ConnectorProduct code: 5C4160Minicap Extended Life PD Transfer Set with Twist ClampProduct code: 5C4482, R5C4482Extra Short product code: 5C4483, R5C4483Extra Long product code: R5C4484ARTG Number: 167416
  • Manufacturer

Manufacturer