Events

Rappel de Pine O Cleen DisinfectantHospital Grade 1.25 Plastic Bottles

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Reckitt Benckiser 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-00207-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-09
  • 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-00207-1
  • 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
    Pine o cleen disinfectant hospital grade (artg: 60110) in 1.25l plastic bottles may have a sub visible stress crack in the bottle neck which may cause the bottle to leak or the cap to break off at the neck and spillage may occur. in the event this happens it will typically occur when the bottle is opened for the first time or within the first few uses.The health risk associated with this issue is accidental exposure to skin and eyes potentially causing transient irritation that would likely be self limiting.If there is contact with the eyes or skin, wash the area with a large amount of water. if irritation persists see your doctor.This recall does not affect any other batches or sizes of pine o cleen disinfectant or any other rb products. this batch has been distributed to retail trade from january 16th 2018 until february 24th, 2018.All product received post february 24th, 2018 is not affected.
  • Action
    Customers are asked to inspect their stock on hand and return affected product as per the instructions given in the Customer Letter

Device

Pine O Cleen DisinfectantHospital Grade 1.25 Plastic Bottles
  • Modèle / numéro de série
    Pine O Cleen DisinfectantHospital Grade 1.25 Plastic BottlesARTG Number: 60110(RECKITT BENCKISER NON-STERILE DISINFECTANTS, WITHOUT CLAIMS 'BENZALKONIUM CHLORIDE')
  • Manufacturer
    Reckitt Benckiser Pty Ltd

Manufacturer

Reckitt Benckiser Pty Ltd