Events

Recall of Microdard ascites puncture 7cm

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 PRODIMED SAS.

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
    2009-07-09
  • 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-lot-microdard-ponction-d-ascite-7cm-prodimed-division-plastimed
  • 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    On 08/07/09, the company PRODIMED division PLASTIMED has withdrawn lot S2009C24 from the reference 6837.10 of the medical device called Microdard ascites puncture 7cm manufactured by PRODIMED SAS-division Plastimed, following the highlighting of a cut at the level of the peelable bag. The company PRODIMED Division PLASTIMED has directly notified the recipients of the offending lot with the message attached (09/07/2009) (19 KB) validated by Afssaps .. This information is intended for directors and correspondents of materiovigilance for dissemination, where appropriate, to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Microdard ascites puncture 7cm
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PRODIMED SAS

Manufacturer

PRODIMED SAS
  • Manufacturer Parent Company (2017)
    Prodimed
  • Source
    LAANSM