Events

Rappel de Cooper Transwarmer Infant Transport Mattress

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Cooper Surgical Inc.

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
    18479
  • Date de mise en oeuvre de l'événement
    2015-05-05
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Downs Distributors Ltd, 9 Airborne Road, North Harbour, AUCKLAND
  • Cause
    Cooper surgical has advised users to discard or return any product that does not display a product lot code or expiration date on each individual unit. cooper surgical is aware that there may be product with customers that has been in inventory for more than five (5) 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.
  • Action
    Product to be returned to supplier

Device

Cooper Transwarmer Infant Transport Mattress
  • Modèle / numéro de série
    Model: Model: CO20421, Affected: All units
  • Manufacturer
    Cooper Surgical Inc

Manufacturer

Cooper Surgical Inc