Events

Recall of Valleylab Bipolar Clamps

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 Tyco Healthcare.

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
    2006-02-21
  • 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-pinces-de-coagulation-bipolaires-valleylab-tyco-healthcare
  • 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
    Tyco Healthcare France SAS has withdrawn from the market on February 20, 2006, the batches and references cited in the attached mail attached to the medical device called Valleylab Bipolar Clamps. This measure follows reports of oxidation. Silver metallic parts (distal ends and connector) of the clamps after resterilization. The company directly notified the recipients of the incriminated lot with the message attached (21/02/2006) (26 KB) validated by the Afssaps .. The competent European authorities concerned are informed of this measure directly by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned.

Device

Valleylab Bipolar Clamps
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Tyco Healthcare

Manufacturer

Tyco Healthcare
  • Source
    LAANSM