Events

Alerte De Sécurité sur EXACTAMIX Inlets

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.

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
    2018-05-07
  • 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_20180507c.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: baxter healthcare exactamix inlets medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its exactamix inlets, details of product are identified as below: exactamix inlet. non-vented, high-volume inlet; product code: h938173; lot number (corrected expiration date) 802278 (9/2018), 802383 (10/2018), 802385 (5/2018) exactamix inlet. vented, high-volume inlet; product code: h938174; lot number (corrected expiration date): 802279 (8/2018), 802280 (8/2018) exactamix inlet. syringe inlet; product code: h938176; lot number (corrected expiration date) 802286 (9/2018) the manufacturer is issuing a voluntary product recall for the above lots due to incorrectly performed over-labeling. the inlets were over-labeled with a blank label, or with a label containing an extended expiration date. according to the manufacturer, the use of an affected inlet that may have lost its sterility due to being used past its actual expiration date may result in a bloodstream infection or other serious adverse health consequences. the customers are required to locate and remove all affected product lots from their facility. according to the local supplier, there are no serious injury and adverse event reported in hong kong. the affected products are distributed in hong kong between 2 june 2017 and 15 february 2018. if you are in possession of the products, please contact your supplier for necessary actions. updated on 10 may 2018.

Device

EXACTAMIX Inlets
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare EXACTAMIX Inlets
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare