Events

Alerte De Sécurité sur Sterile Disposable Vaginal Speculums

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Taizhou Kangjian Medical Equipment Co..

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
    2016-05-18
  • Date de publication de l'événement
    2016-05-18
  • 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_20160518.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: sterile disposable vaginal speculums manufactured by taizhou kangjian medical equipment co., ltd it has come to the attention of the medical device control office that several maternal and child health centres of the department of health have reported incidents relating to disposable vaginal speculums manufactured by taizhou kangjian medical equipment co., ltd. the incidents involved breakage of the handles and/or blades of the speculums, dislodgement of screwing rods and presence of black debris inside the packages. the affected vaginal speculums are identified as follows: cusco style, sterile, 105 mm (length) x 22 mm (width), model number ta3201, lot number 20150320 cusco style, sterile, 130 mm (length) x 28 mm (width), model number ta3203, lot number 20150320 the issues have been reported to the local supplier, tin ho enterprises co. ltd. and investigation is underway. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2016.

Device

Sterile Disposable Vaginal Speculums
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Sterile Disposable Vaginal Speculums Manufactured by Taizhou Kangjian Medical Equipment Co., Ltd
  • Manufacturer
    Taizhou Kangjian Medical Equipment Co.

Manufacturer

Taizhou Kangjian Medical Equipment Co.