Events

Recall of Re-entry Catheters OUTBACK-LTD

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 Cordis Corporation Miami.

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
    2008-08-25
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-tous-les-lots-de-catheters-a-re-entree-outback-ltd-de-la-reference-otb42120-cordis-corporation
  • 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
    On 21/08/2008, the company Ethicon SAS has withdrawn from the market all batches of the reference OTB42120 of the medical device called: Re-entry Catheters OUTBACK-LTD, manufactured by Cordis Corporation Miami. This withdrawal follows the registration of several claims relating to a separation of the cannula and the deployment slide on the handle Catethers, thus preventing the retraction of the cannula in the body of the catheter .. The company Ethicon SAS has directly notified the recipients of the incriminated lots using the attached message (25/08/2008) (33 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities (concerned) are informed of this measure by the manufacturer.

Device

Re-entry Catheters OUTBACK-LTD

Manufacturer

Cordis Corporation Miami