Events

Rappel de Cooper Surgical Inflatoball Pessary

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
    21343
  • Date de mise en oeuvre de l'événement
    2017-04-28
  • 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
    The manufacturer is recalling specific lots of its inflatoball pessary and inflatoball pessary kit products. these products are being recalled due to a labelling error on the secondary package. the current secondary package, a box, incorrectly states that the product is latex free. the product is made with 100% latex., the label on the package that contains the product and the ifu correctly states that the pessary is manufactured from latex rubber.
  • Action
    Product to be returned to supplier

Device

Cooper Surgical Inflatoball Pessary
  • Modèle / numéro de série
    Model: CO-MXPINFM and CO-MXPINFL, Affected: LOT NUMBER: 178321 and 185809
  • Manufacturer
    Cooper Surgical Inc

Manufacturer

Cooper Surgical Inc