Events

Recall of Manual pulmonary respirator (RPM, Manual insufflator)

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 Unomedical France.

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
    2009-10-16
  • 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-lots-du-dispositif-medical-respirateur-pulmonaire-manuel-rpm-insufflateur-manuel-unomedical
  • 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    On 15/10/2009, the company Unomedical France has withdrawn from the market the batches of the references cited in the appendix (16/10/2009) (12 ko) of the recall letter of the medical device called: Manual pulmonary respirator (RPM, Manual insufflator ), manufactured by Unomedical (Mexico) following the discovery of a manufacturing defect in the production of this device. Indeed, on some manual pulmonary breathing apparatus (manual insufflator), the duckbill valve and the retaining ring inside the patient valve housing could dislodge and fall into the balloon or body of the patient. manual resuscitator (RPM). If this occurs, the Manual Resuscitator (RPM) may lose its ability to produce the positive pressure needed to ventilate the patient, which may compromise ventilation to the patient and potentially have serious consequences for the patient's condition. of the patient's health. The company Unomedical France has directly notified the recipients of the incriminated lots with the message attached (16/10/2009) (71 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 have been informed of this measure by manufacturer.

Device

Manual pulmonary respirator (RPM, Manual insufflator)

Manufacturer

Unomedical France