Events

Rappel de Medi-vac Flex Advantage Suction Liners and Canisters

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 Cardinal Health.

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
    13621
  • Date de mise en oeuvre de l'événement
    2012-10-24
  • 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: Medline International New Zealand Limited, 14 George Bourke Drive, Mt Wellington, Auckland 1060
  • Cause
    Safety alert notice advising customers that some users of the product:, 1. may be testing functionality by "bumping" the medi-vac liners. as indicated in the warning section of the product's dfu, premature shut-off of the vacuum may occur if the canister is bumped., 2. may be testing vacuum/ suction by occluding the medi-vac liner's patient port with their finger. this practice may activate the mechanical shut-off and consequently turn offf the vacuum. occlusion of the patient port as a testing method is not included in the product's dfu and therefore is not a recommended test.
  • Action
    Manufacturer to issue advice regarding use

Device

Medi-vac Flex Advantage Suction Liners and Canisters
  • Modèle / numéro de série
    Model: 65652-6ll, 65652-616, 65652-631, 65651-910C, 65651-920C and 65651-930C, Affected: All lots
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health