Events

Alerte De Sécurité sur Premise Universal Restorative Body Syringe and Unidose, Shade A2

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

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
    2014-09-12
  • Date de publication de l'événement
    2014-09-12
  • 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_20140912.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: kerr premise universal restorative body syringe and unidose, shade a2 medical device manufacturer, kerr corporation, has issued a medical device safety alert concerning its premise universal restorative body syringe and unidose, shade a2, with the following details: product descriptions: a) refill - syringe premise a2; and b) refill - unidose premise a2 part no.: a)32618; b) 32651 serial no.: a) 4941320; 4946443; 4906963; b) 4908202; 4890805; 4890804; 4890806; 4946447 shipped between june 2013 to november 2013 the manufacturer received some complaints that certain units within certain lots of premise a2 composite may be sticky and/or difficult to use. there is no safety issue associated with using the product. affected users should review to determine if they have any of the affected products in their inventory, and users can choose to return the affected product for replacement if not satisfied. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 sep 2014.

Device

Premise Universal Restorative Body Syringe and Unidose, Shade A2
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Kerr Premise Universal Restorative Body Syringe and Unidose, Shade A2
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation