Events

Alerte De Sécurité sur Vented Paclitaxel Set

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

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
    2015-11-05
  • Date de publication de l'événement
    2015-11-05
  • 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_20151105.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: baxter healthcare vented paclitaxel set medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning vented paclitaxel set. the affected product code and lot numbers are as follows: product code (lot number): mmc9627s (14h13v434) product code (lot number): vmc9627 (14i05t696, 14k19t380, 15b17t404) the manufacturer is voluntarily issuing a recall for the above referenced lots due to complaints for leaks at the spike’s air vent subassembly. according to the manufacturer, a leak in a paclitaxel set may result in a breach in sterility of the fluid path with subsequent contamination of the solution. if the leak was not detected during priming or initial set up, it would lead to serious adverse health consequences. besides, the leak may result in skin contact that would lead to potential irritation of skin. the manufacturer is advising users to inspect and quarantine any affected stock for return to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 5 november 2015.

Device

Vented Paclitaxel Set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare Vented Paclitaxel Set
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare