Events

Recall of Ercelab Vermed Company

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 Ercelab Vermed, Moria and Odon Life Technology.

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
    2003-03-04
  • 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-de-dispositifs-medicaux-des-societes-ercelab-vermed-moria-et-odon-life-technology
  • 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
    At the request of the Agency and as a precaution, the companies Ercelab Vermed, Moria and Odon Life Technology withdraw from the market the medical devices listed below following a doubt concerning the interpretation of the results of one of the biological indicators placed in the sterilization cycle carried out by a common subcontractor. Ercelab Vermed Company. valve extensions reference 85016 lot 44463A This device is used when performing urodynamic tests. . Moria company:. . microkeratome rings and heads reference 19321/130 batch DISP-1 00. aspiration tubes for microkeratomes reference 19138 lot TUELSK 05. slides for microkeratome M2 reference 19329 batches LAM M2F 037 and 038.. Odon Life Technology Company. polypectomy loops reference 02APO3001 lot 02472 and references 02APO4001 lots 02474 and 02475.. Recipients have been informed directly by the manufacturers

Device

Ercelab Vermed Company

Manufacturer

Ercelab Vermed, Moria and Odon Life Technology
  • Source
    LAANSM