Events

Alerte De Sécurité sur Coseal Surgical Sealant

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

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
    2011-07-27
  • 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_20110727.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
    Alert on product recall: coseal surgical sealant baxter healthcare ltd is voluntarily recalling one lot of coseal surgical sealant (product code: 934074, lot no. ha090947, with expiry date 08/31/11) as a precautionary measure. one parameter of the device in the manufacturer’s stability test is found to be out of specification and there is possible failure for the product to gel appropriately. the manufacturer claimed that such failure does not represent risk for patient’s life. the manufacturer further asked the users to stop using the above lots and to quarantine any units that may be put in the users’ inventory. if the product cannot gel appropriately, users may use of a second kit of product or alternative method for hemostasis. the measures have been described in the ifu of the device. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Coseal Surgical Sealant
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: [27 Jul 2011] Coseal Surgical Sealant
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd