Recall of Cadd infusion pumps

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 Smiths Medical.

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
    2007-05-31
  • Event Country
  • Event Source
    ANSM
  • Event Source URL
  • 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
    In agreement with Afssaps, Smiths Medical informed the users of Cadd infusion pumps on May 26, 2007, of the recall of the cassettes whose lot number ends with "X16". This recall was made for the infusion of Flolan * on April 6, 200.. Further investigations have shown a risk of pH modification of several other infused solutions. The providers and health institutions concerned by this recall in France have received the attached letter (26/05/2007) (19 KB) The other European competent authorities have been informed of this measure by Afssaps.

Device

  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer

Manufacturer