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
    2006-03-23
  • 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-de-lots-d-adaptateurs-pour-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 (see annexed mail (13/07/2005) (50 ko)) of external adapters for Mono or Dual Cath catheters following several cases of rupture at the connection piece, due to bumps that weaken the silicone. As new incidents have occurred, HEMOTECH remembers these adapters packaged individually or in light or complete trays of Mono and Dual Cath .. establishments concerned were notified directly by the attached letter (23/03/2006) (115 KB) validated by Afssaps. This information concerns health facility directors and local correspondents of materiovigilance for distribution to hemodialysis, nephrology, intensive care, surgery, operating theaters and hospital pharmacies. This device has only 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