Events

Rappel de Beckton Dickinson PrepMate™ Vial Cap

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 manufacturer #1479.

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
    19800
  • Date de mise en oeuvre de l'événement
    2016-02-24
  • 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: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Cause
    The prepmate™ vial cap is the spare lid sold separately to re-seal the bd surepath™ collection vial post processing., some prepmate™ vial caps are cracked on the top and have the potential to cause leakage., the concern with any leakage from the vial after specimen collection is that it could cause irritation or inflammation to skin or mucous membranes since there is an increased risk of chemical or biological exposure. cytological specimens may contain infectious agents. if there is contact due to leakage or splashing (preservative fluid contains 24% ethanol and <1% formaldehyde), it can also cause temporary (non-permanent) vision issues.
  • Action
    Product to be destroyed

Device

Beckton Dickinson PrepMate™ Vial Cap
  • Modèle / numéro de série
    Model: 490505, Affected: Lot Nosd: 5029674 5051867 5083935 5117563 5176869 5202623 5198835
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479