Events

Rappel de Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tube feeding)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Merck 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-2016-RN-00768-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-10
  • 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-2016-RN-00768-1
  • 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
    Merck has received a product complaint regarding concerns of colour indications on packaging being insufficiently clear and the possibility of end users confusing the colour coding in the explanatory box with the corresponding colour on the ph strip. please note that with these ph indicator papers, the printed scale on the packaging serves purely as an instruction on how to use the product. the ph is only identified by comparison of the test square with the printed colours on the test strip itself.
  • Action
    Merck is advising users to inspect stock and remove any remaining strips of the affected lots from use. Affected stock will be replaced with a revised indicator strip or a credit note issued. This action has been closed-out on 20/02/2017.

Device

Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tub...
  • Modèle / numéro de série
    Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tube feeding)Catalogue number: IN01Order code: NAAUIN01Lot Numbers: 509029, 604025ARTG number: 260068
  • Manufacturer
    Merck Pty Ltd

Manufacturer

Merck Pty Ltd
  • Société-mère du fabricant (2017)
    Merck KGaA
  • Source
    DHTGA