Alerte De Sécurité sur microbial contaminated protective wipes and adhesive removers

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

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
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Press release
  • Cause
    Recall of microbial contaminated protective wipes and adhesive removers annex the department of health (dh) today (april 15) endorsed a local medical device supplier, smith & nephew (s&n) ltd's proposal to recall eight types of its devices imported from the states (see annex) because of a potential for pathogenic contamination. a dh spokesman explained that the eight products belonged to two categories. the first comprises five types of protective wipes, used for skin preparation before the removal of tapes and films. the second consists of three types of adhesive removers which can clean adhesive residues from the skin. the spokesman said, "s&n's initiation comes following the dh's earlier call this january, advising the public not to use a us manufacturer, triad group's alcohol swab preparations after the us food and drug administration's blanket market recall of the items because of the potential risk of contamination by a bacterium, bacillus cereus. at the same time, local medical device traders are advised to check if any of their products have been affected as a consequence." bacillus cereus is known to be able to cause life-threatening infections among at-risk populations, including surgical and immuno-compromised patients. thus far however, the dh has not been notified of any such infections. s&n alerted the dh that its parent company in the states, smith & nephew inc, has just announced a global recall on the above eight products as the items were also manufactured by the triad group and have been found to have the same risk of contamination by bacillus cereus. the spokesman remarked that in fact s&n had only imported the first two items in the table, remove universal adhesive remover wipes and skin-prep protective wipes for sale in hong kong. therefore, the two would be the major targets of s&n's present recall. "however, mindful of the option of internet trading and also the possibility of possession by travellers, return of any of the other six items would also be handled," the spokesman clarified. a hotline 2648 7770 has been set up by s&n for related enquiries. the spokesman finished by stating that while dh will continue to monitor developments of the triad group recall and s&n's related act in hong kong, patients and healthcare providers are advised to stop using products under recall in hand immediately. they may choose substitutes from alternatives available on the market. ends/friday, april 15, 2011 issued at hkt 19:25.


  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of microbial contaminated protective wipes and adhesive removers
  • Manufacturer