Events

Recall of unkown device

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 N/A.

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
    2004-03-15
  • 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-raccords-equipant-des-rampes-haute-pression-centrales-d-air-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
    It has been detected by the technical services of AGA Medical a case of crack on a brass fitting equipping a high pressure ramp of gaseous medical air distribution unit. The company CAHOUET, manufacturer of these connections, proceeds to the removal of the parts considered potentially defective .. The ramps concerned are the following: reference CAHOUET / AGA Médica. medical air reach ramp - 1 bottle VL2135B / R61238. medical air wall ramp - 2 bottles VL2231A / R61238. medical air wall ramp - 3 bottles VL2316A / R612389. Serial numbers 64294 to 98, 64444 to 47, 65828 to 31, 66238 to 41, 66386 to 87, 66390 to 91, 77176 to 78, 77349 to 50 correspond to deliveries between April and October 2003 .. These fittings are going to be replaced as soon as possible by the authorized staff of AGA Medical who informed the institutions concerned on March 6.

Device

unkown device
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM