Events

Alerte De Sécurité sur Rusch Belly Bag Urine Collection Bag with Hip Belt

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

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
    2013-04-05
  • Date de publication de l'événement
    2013-04-05
  • 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_20130405a.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: teleflex rusch belly bag urine collection bag with hip belt the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning rusch belly bag urine collection bag with hip belt [model and part no.: belly bag 1000ml b1000, belly bag with 24inch drain b1000ct, belly bag with sample port b1000p], manufactured by teleflex medical. the manufacturer has issued a voluntary recall for the above products as the packaging may be compromised, and therefore the sterility of the product cannot be guaranteed. if non-sterile products are used, there is a possible risk of infection. the manufacturer requests that medical staff to check their inventory for product within the scope of this field action. they should cease use and distribution of the affected product; and to quarantine immediately and return the affected product to teleflex for replacement. they also advises distributor of the affected products to the field safety notice to all of their customers. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con252005 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 april 2013.

Device

Rusch Belly Bag Urine Collection Bag with Hip Belt
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Teleflex Rusch Belly Bag Urine Collection Bag with Hip Belt
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical