Manual pulmonary respirator (RPM, Manual insufflator) 의 리콜

Recall

2009-10-16

France

ANSM

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

On 15/10/2009, the company Unomedical France has withdrawn from the market the batches of the references cited in the appendix (16/10/2009) (12 ko) of the recall letter of the medical device called: Manual pulmonary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.