Events

Rappel de Actifuse ABX and Actifuse MIS System

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-2015-RN-00774-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-08-25
  • 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-00774-1
  • 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
    Baxter healthcare is issuing a recall of actifuse abx and actifuse mis system products with expiry before 29 july 2017 due to the possibility that the products may have endotoxin levels above specification criteria. in surgical procedures where there is device contact with the cerebrospinal fluid through a dural opening (iatrogenic injury), the use of a medical device with increased endotoxin levels may augment the typical inflammatory reaction to surgery and contribute to adverse health consequences. baxter has not received product-related adverse event reports that can be linked to cerebrospinal fluid exposure to increased levels of endotoxins.
  • Action
    Users are asked to inspect their stock and to remove affected product from their facility and to contact Baxter Customer service to arrange replacements. This action has been closed-out on 05/09/2016.

Device

Actifuse ABX and Actifuse MIS System
  • Modèle / numéro de série
    Actifuse ABX and Actifuse MIS SystemProduct Codes: 506005078047 Actifuse ABX, 1-2 mm, 2.5 mL506005078048 Actifuse ABX, 1-2 mm, 5.0 mL506005078049 Actifuse ABX, 1-2 mm, 10.0 mL506005078057 Actifuse ABX, 1-2 mm, 20.0 mL,506005078059 Actifuse ABX, 1-2 mm, 1.5 mL506005078069 Actifuse MIS System, 1-2 mm, 7.5 mL506005078071 Actifuse MIS System Refill, 1-2 mm, 7.5 mLLot Numbers: ALLARTG Numbers: 188736 & 193684
  • Classification du dispositif
    Orthopedic Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd