Events

Recall of Combicath

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by PRODIMED - Division PLASTIMED.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2005-05-09
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-du-dm-combicath-prodimed-division-plastimed
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Action
    The company PRODIMED - Division PLASTIMED withdrew from the market on 06.05.2005 the batch S2004G27 of the medical device called Combicath reference 58228 19 following difficulties of sampling related to the cutting length, too short, of the internal catheter .. This defect is visualized during sampling because the outer catheter remains obstructed by a plug that should normally be ejected from the outlet of the internal catheter. This device is used for protected bronchial distal sampling. The company has directly notified the recipients of the incriminated lot with the enclosed message validated by Afssaps (06/05/2005) (45 KB). This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European competent authorities are informed of this measure by the manufacturer.

Device

Combicath

Manufacturer

PRODIMED - Division PLASTIMED
  • Source
    LAANSM