Events

Recall of Exchange of Adapters for Mono and Dual Cath Catheters

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 HEMOTECH.

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
    2005-07-13
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/echange-d-adaptateurs-pour-catheters-mono-et-dual-cath-de-la-societe-hemotech
  • 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 Afssaps was informed on July 6, 2005 by the company HEMOTECH of an exchange of external adapters for Mono or Dual Cath catheters following several cases of rupture at the connection piece, due to asperities weakening the silicone. The manufacture of adapters has been modified since June 15, 2005; the new devices, starting from lot MABX130 no longer present this risk .. The concerned users were warned directly by means of the enclosed mail (13/07/2005) (50 KB), sent on June 30, 2005, asking them to replace the adapters contained in the trays with the catheters, by modified devices sent in exchange. This information concerns the directors of health establishments and the local correspondents of materiovigilance for diffusion to the services of hemodialysis, of nephrology, resuscitation, surgery, operating theaters and pharmacies of hospitals .. This device has been marketed in France.

Device

Exchange of Adapters for Mono and Dual Cath Catheters
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    HEMOTECH

Manufacturer

HEMOTECH
  • Source
    LAANSM