Events

Rappel de BVM (Bag-Valve-Mask) Manual Resuscitation Systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical Developments International Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00838-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-07-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00838-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Medical developments international has identified the possibility that the valve of the bvm manual resuscitation system may become stuck during storage. this could result in the intended tidal volume not being delivered through the valve, which may cause a delay in treatment.The instructions for use (ifu) provided with these products include the requirement to ensure the bag, valve and oxygen delivery is functioning correctly prior to use.
  • Action
    Medical Developments International is requesting users inspect their stocks and quarantine all units from the affected batch numbers, then complete the supplied Reply Form and email or fax it back so that we may arrange collection and issue credit. Please complete the Reply Form even if you have no stock which is subject to recall, as we require this information to reconcile the process.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Modèle / numéro de série
    BVM (Bag-Valve-Mask) Manual Resuscitation SystemsCatalogue Number: RS-7595-BVMDAWBatch Numbers: up to 1170328006Catalogue Number: RS-7595-BVMDABatch Numbers: up to 1160629050Catalogue Numbers: RS-7595-BVMDC, RS-7595-BVMDC3Batch Numbers: up to 1160728029Catalogue Number: RS-7595-BVMDC3Batch Numbers: up to 11600922002ARTG Number: 147543
  • Manufacturer
    Medical Developments International Limited

Manufacturer

Medical Developments International Limited