Events

Rappel de Hypochlorite 1% Solution & Hypochlor 1% Solution

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Dentalife 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-2015-RN-01222-2
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-12-15
  • 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-2015-RN-01222-2
  • 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
    It has come to dentalife's attention that there is a contamination risk in two batches of sodium hypochlorite solution small particles of black matter have been observed floating in several 1.25l bottles of the solution. the issue has been investigated and the material is suspected to be particles of a food grade grease used to lubricate the volumetric filling device as part of the manufacturing process.
  • Action
    Dentalife is advising users to discard affected stock for replacement. This action has been closed-out on 29/08/2016.

Device

Hypochlorite 1% Solution & Hypochlor 1% Solution
  • Modèle / numéro de série
    Hypochlorite 1% Solution & Hypochlor 1% SolutionProduct Codes: DL0403, HPH125 (1.25L) and DL0401 (500mL)Batch Numbers: 2356 and 4209Expiry Dates: 06/17 and 09/17ARTG Number: 160242
  • Manufacturer
    Dentalife Australia Pty Ltd

Manufacturer

Dentalife Australia Pty Ltd