Events

Rappel de Smiths Medical 50 ml CADD® Medication Cassette

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 Smiths Medical MD 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
    22071
  • Date de mise en oeuvre de l'événement
    2017-10-13
  • 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: Smiths Medical Australasia Pty Ltd, c/o KPMG, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland
  • Cause
    The manufacturer has become aware that certain non flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. normally the pressure plate has a tunnel for the pumping tube, however on the affected models there is an arch on the pressure plate and pumping tube is pushed up., under delivery of medication may result from the tubing becoming partially or completely occluded when the affected cassette is attached to the pump.
  • Action
    Product to be returned to supplier

Device

Smiths Medical 50 ml CADD® Medication Cassette
  • Modèle / numéro de série
    Model: 21-7001-24, Affected: Lot Nos: multiple (expiration date range March 2017 and March 2022)
  • Manufacturer
    Smiths Medical MD Inc

Manufacturer

Smiths Medical MD Inc