Events

Recall of Penta syringe 60 ml L / L

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 PENTAFERTE.

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
    2007-12-03
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-seringue-penta-60ml-l-l-pentaferte
  • 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 30/11/07, the company PENTAFERTE removed from the market lots 09G05; 9:01; 9:04; 09L01; 09L02 and 09L03 of the reference 002022970F of the medical device called Penta syringe 60 ml L / L, following reports mentioning tripping alarms on some syringe pumps, inaccuracies in volumes taken and leaks due to poor sliding of the piston and a deformation of the seal .. The company PENTAFERTE directly warned the recipients of the incriminated lots with the message attached (03/12/2007) (25 ko) validated by Afssaps .. This information s' address to directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Penta syringe 60 ml L / L
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PENTAFERTE

Manufacturer

PENTAFERTE
  • Source
    LAANSM