Events

Alerte De Sécurité sur VACUETTE Safety Blood Collection Sets and Blood Collection Sets

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Greiner Bio-One.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-04-02
  • Date de publication de l'événement
    2013-04-02
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130402.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: greiner bio-one vacuette safety blood collection sets and blood collection sets medical device manufacturer, greiner bio-one, has issued a medical device safety alert concerning vacuette safety blood collection sets and blood collection sets. according to the manufacturer, the vacuette safety blood collection set and accessory may display leaking during use due to a crack on the luer connector piece. due to claim from france and due to a supplier’s notification after a supplier audit, greiner bio-one decided to recall some products from the market. the manufacturer estimates the risk for the user as being low. the root cause of the defect is attributed to the fact that the connectors of the defective lot have not been annealed. this non-annealing could brittle the connector and may lead to a crack in the connector. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 2 april 2013.

Device

VACUETTE Safety Blood Collection Sets and Blood Collection Sets
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Greiner Bio-One VACUETTE Safety Blood Collection Sets and Blood Collection Sets
  • Manufacturer
    Greiner Bio-One

Manufacturer

Greiner Bio-One