Events

Rappel de OM040R - Doyen-Collin Mouth Gag 120mm Produced between Feb 2016 and Oct 2017 inclusive

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par B Braun Australia Pty Ltd.

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-2018-RN-00124-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-03-14
  • 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-2018-RN-00124-1
  • 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
    Braun has been notified by the manufacturer that an error in the initial manufacture of these items has been identified resulting in a potential for the protective sleeves to become “sticky” after reprocessing.It has been determined that the used plastic sleeves of the instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing.
  • Action
    B Braun is advising users to ensure that the affected products are no longer used and to complete and fax the Facsimile Reply Form provided with the Customer Letter to them so that they may arrange for devices to be collected and repaired.

Device

OM040R - Doyen-Collin Mouth Gag 120mm Produced between Feb 2016 and Oct 2017 inclusive
  • Modèle / numéro de série
    OM040R - Doyen-Collin Mouth Gag 120mmProduced between Feb 2016 and Oct 2017 inclusiveARTG Number: 99164
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd