Events

Recall of Parap180 single-branch ventilation circuit for portable respirator for Parapac ventilator

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 Int'Air 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
  • Event ID
    R1612809
  • Date
    2017-01-17
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/circuit-de-ventilation-monobranche-parap180-pour-respirateur-portable-pour-ventilateur-parapac-type-p200dep-int-air-medical-rappel
  • 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
    ANSM has been informed of a batch withdrawal made by INT'AIR MEDICAL and implemented by the distributor TELEFLEX MEDICAL. The users concerned received the attached mail (17/01/2017) (88 KB). This safety action is registered at ANSM under the number R1612809.

Device

Parap180 single-branch ventilation circuit for portable respirator for Parapac ventilator
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Int'Air Medical

Manufacturer

Int'Air Medical