Events

Recall of Suprapubic bladder drainage set CYSTODRAIN

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 Coloplast.

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
    2009-12-28
  • 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-du-dispositif-medical-set-de-drainage-vesical-sus-pubien-cystodrain-par-coloplast
  • 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 24/12/09, the company Coloplast removed from the market batches 9061634, 9062559, 9061644, 9072540, 9072538, 9090199 of the reference AJ7015 and AJ7515 of the medical device called "Suprapubic bladder drainage set CYSTODRAIN" manufactured by Coloplast, following the detection of a trocar diameter defect making the use of the set impossible: the drainage probe can not be inserted into the trocar. Colplast directly notified the recipients of the offending batches to the trocar. help message attached (28/12/2009) (31 KB) validated by Afssaps. This information is addressed to the 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

Suprapubic bladder drainage set CYSTODRAIN
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Coloplast

Manufacturer

Coloplast