Events

Alerte De Sécurité sur Sterile Products

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

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
    2013-08-19
  • Date de publication de l'événement
    2013-08-19
  • 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_20130819.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 products from nuvision pharmacy the united states food and drug administration (fda) has issued a press release to remind health care providers about safety concerns with all sterile drug products made and distributed by nuvision pharmacy of dallas, texas. the fda advises that health care providers should not administer any nuvision pharmacy sterile products to patients because the products’ sterility is not assured. if the product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections this alert follows the fda’s notice on 18 may 2013 recommending that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for nuvision pharmacy sterile products, quarantine those products, and not administer them to patients. according to the nuvision pharmacy’s website, injectables using higher strengths of hyaluronic acids in various delivery viscosities have been developed. the company also says that they can formulate products for wrinkle treatment (http://nuvisionpharmacy.Com/?id=13). for details, please visit the following fda website: http://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm365402.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 august 2013.

Device

Sterile Products
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Sterile Products from NuVision Pharmacy
  • Manufacturer
    NuVision Pharmacy

Manufacturer

NuVision Pharmacy