Events

Recall of Hem-o-lok wide Polymer clips

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 Teleflexmedical.

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
    2009-01-14
  • 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-du-dispositif-medical-hem-o-lok-large-polymer-clips-societe-teleflex-medical
  • 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
    On January 6, 2009, Teleflexmedical withdrew from the market the batches listed in the annex of the recall, the medical device: ligature clips of the brand Weck on the product Hem-o-lok wide Polymer clips (reference WK 544240) manufactured by Teleflex Medical, in addition to the recall initiated in September 2008. The company Teleflexmedical directly notified the recipients of the offending lots with the message attached (14/01/2009) (40 KB). This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer. Recall of the 26/09/08

Device

Hem-o-lok wide Polymer clips
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Teleflexmedical

Manufacturer

Teleflexmedical