Retiro De Equipo (Recall) de EasiCath and EasiCath LuerLock probes

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Coloplast.

¿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
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  • URL de la fuente del evento
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    On 18/11/2008, the company Coloplast removed from the market the batches of the references cited in the recall letter of the medical device called: EasiCath and EasiCath LuerLock probes, manufactured by Coloplast S / A following the discovery during the inspection of routine of a quality defect on some probes .. In fact, the incriminated lots can contain probes whose proximal end is totally or partially severed and consequently cutting, the use of these condes can cause lesions at the level of 'urethra. The company coloplast directly notified the recipients of the incriminated lots with the message attached (21/11/2008) (77 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned, wholesaler-distributors and pharmacists of dispensaries which relay it near the customers concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.


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