Events

Rappel de Volcano SpinVision Sterile Equipment Cover

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 Volcano Corp.

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
    19957
  • Date de mise en oeuvre de l'événement
    2016-03-29
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Cause
    Potential that the product may be labelled beyond its expiration date. a number of units at the manufacturing facility may have been shipped in a package with an inventory label containing an expiration date that is one or more months later than the correct expiration dates shown on the product's primary and secondary packaging., the primary packaging includes a label on each pouch containing individually packaged products. the secondary packaging, which is also the shipping box, also contains a label identifying the product by part and lot number., the correct expiration dates located on the labels of the primary and secondary packaging for these products is no earlier than march 2018, so prompt attention to this notice will prevent expired product from mistakenly remaining in inventory. while month and year are listed, the shelf life extends through the last day of the listed month.
  • Action
    Manufacturer to issue advice regarding use

Device

Volcano SpinVision Sterile Equipment Cover
  • Modèle / numéro de série
    Model: 891BG-10, Affected:
  • Manufacturer
    Volcano Corp

Manufacturer

Volcano Corp
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA