Events

Recall of Intubation bronchoscopes and fiberscopes

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 Storz.

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
  • Event ID
    201410599
  • Date
    2014-09-24
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/bronchoscopes-et-fibroscopes-d-intubation-storz-rappel-de-lots
  • 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 ANSM has been informed of the implementation of a recall carried out by the company karl STORZ. The users concerned have received the attached letters (24/09/2014) (647 ko). Two letters have been sent. distributed according to whether or not the establishments have a STERRAD dipositive. Indeed, this action follows a problem of compatibility of bronchoscopes and fibroscopes with the STERRAD device (safety information 201318024 released on 14/02/14) This safety action is registered at ANSM under n ° 201410599. You will be able to check its status on the Directory of Material Safety Reports by entering this registration number.

Device

Intubation bronchoscopes and fiberscopes
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Storz

Manufacturer

Storz