Rappel de National Workplace First Aid Kit & Sports & Outdoors First Aid Kit National Workplace First Aid Kit, Sports & Outdoors First Aid Kit

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CIP Medical Supplies T/A Caseinpoint 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-00788-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-15
  • Pays de l'événement
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
  • 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 recently come to case in point's attention that some items in the first aid kits you purchased under the first aid factory brand in the last 12 months contain items labelled as being sterile when they are actually not sterile. this occurred due to a manufacturing error. this issue is unlikely to pose any risk to health, however there is a theoretical risk that the use of an un-sterile wound dressing on an immunocompromised patient could result in an infection. there have been no reports of injuries or adverse events related to this issue.
  • Action
    Case In Point is recalling the affected kits. Customers returning the affected items for replacement are requested to complete the returns form attached and include the returned items in the prepaid post bag provided with the returns form and send to The First Aid Factory within the next 30 days. Customers returning the affected items for are requested to complete the returns form attached and include the complete first aid kit or refill pack, with the returns form in the prepaid post bag provided and send to The First Aid Factory within the next 30 days. This action has been closed-out on 04/08/2016.

Device

  • Modèle / numéro de série
    National Workplace First Aid Kit & Sports & Outdoors First Aid KitNational Workplace First Aid KitBatch number: 20121214D-WP-L Expiry date: 01/2016Sports & Outdoors First Aid Kit Batch number: 20121214C-S&O; Expiry date: 01/2016ARTG number: 172274
  • Manufacturer