Events

Alerte De Sécurité sur Askina Gel and Calgitrol Paste

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

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
    2018-05-02
  • Date de publication de l'événement
    2018-05-02
  • 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_20180502a.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: b. braun hospicare ltd askina gel and calgitrol paste medical device manufacturer, b. braun hospicare ltd., has issued a medical device safety alert concerning its askina gel and calgitrol paste [article number: 14291, 001419n, 001419nru, 001419s, 001419sbr, 001419ses, 001419sescp, 001419sf, 001419sfr, 001419sru, 6241001, 6241505, 6241505f, 6241510, 6242501, 6242501fr, 6245001]. in the manufacturing site, it was determined that the irradiation dose qualified for sterilization of the above mentioned products was too low. in consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 10-6. the effect cannot be limited to specific batches. according to the manufacturer, there was no market feedback on any adverse patient outcome which could be associated to the above described observation. however, the manufacturer decided to recall the affected products from the market as a preventive measure. the affected users are asked to take the following actions: identify and quarantine the affected devices; do not use affected devices anymore; patients with affected devices in use should be monitored carefully. if clinically uneventful, an exchange of the product is not indicated. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 may2018.

Device

Askina Gel and Calgitrol Paste
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: B. Braun Hospicare Ltd Askina Gel and Calgitrol Paste
  • Manufacturer
    B

Manufacturer

B