Events

Alerte De Sécurité sur Dual Luer Lock Caps

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.

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
    2013-09-23
  • Date de publication de l'événement
    2013-09-23
  • 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_20130923.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 dual luer lock caps the u.S. food and drug administration (fda) have posted a press release issued by baxter concerning its dual luer lock caps with the followings: product code: 2c6250 lot number: 10043 and 10044 affected lots were distributed to customers between 19 jun 2013 and 20 aug 2013. there is the presence of loose particulate matter found in the packaging of the affected products. particulate matter entering the fluid path from the luer lock caps may result in thrombotic and embolic events, including pulmonary embolism, myocardial infarction and stroke. there have been no reported complaints associated with this issue. according to the manufacturer, customers should not use product from the two recalled lots and should locate and remove all affected product from their facility. affected lots should be returned to baxter. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm369253.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 23 september 2013.

Device

Dual Luer Lock Caps
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Dual Luer Lock Caps
  • Manufacturer
    Baxter

Manufacturer

Baxter