Events

Rappel de 0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare 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-2014-RN-01091-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-10
  • 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-2014-RN-01091-1
  • 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
    Investigation of a small number of customer complaints has confirmed a reported problem of solution leaking into the overpouch. it has been identified that the issue was caused by a component used in the manufacture of the lots above, and is confined to these batches. there are no other affected products. this issue potentially impacts the sterility of the irrigation fluid.
  • Action
    Customers are advised to locate and remove all of the affected products and lot numbers from their facility. The affected product should be returned for credit by contacting Baxter Healthcare Customer Service. Also, customers are advised to bring this matter to the attention of relevant prescribers within their hospital so that any patient who is undergoing infusion, or has very recently received an infusion of this product, can be monitored. This action has been closed-out on 22/08/2016.

Device

0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml
  • Modèle / numéro de série
    0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml0.9% Sodium Chloride for Irrigation 2000mlProduct Code: AHB7616Batch Numbers: S77N6 & S77R8 (Expiry Date: July 2016) and S78F1 (Expiry Date: Aug 2016)Water for Irrigation 2000mlProduct Code: AHB7606Batch Numbers: S77N5 (Expiry Date: July 2016) and S78A6 (Expiry Date: Aug 2016)ARTG Number: 155928
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd