Events

Rappel de Transwarmer Infant Transport Mattress

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ferno 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-00371-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-30
  • 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-00371-1
  • 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
    Coopersurgical has identified that there may be product with customers that have been in inventory for more than five years. some users of the transwarmer infant transport mattress may have removed individual units from the original packaging and have been using the device past the labelled and recommended expiration date.Serious burns have been reported in the past and could occur if the products are not stored under the labelled conditions or used beyond the recommended shelf life. coopersurgical has received three complaints from the field indicating that the product may activate at higher than labelled temperatures.
  • Action
    CooperSurgical is requesting all users to review their inventory and discard or return any product that does not display a product LOT code or expiration date on each individual unit. The brands affected include CooperSurgical and NovaPlus labelled TransWarmer Infant Transport Mattress. The LOT code and expiration date can be located on the top left corner of the individual pouches. All new units will have the lot and expiry date on the individual unit packaging. This action has been closed-out on 17/05/2017.

Device

Transwarmer Infant Transport Mattress
  • Modèle / numéro de série
    Transwarmer Infant Transport MattressCatalogue number: 20421All batchesOrder codes: BPOD2-TRANS06 / BPOD2-NEON03ARTG number: 221364
  • Manufacturer
    Ferno Australia Pty Ltd

Manufacturer

Ferno Australia Pty Ltd