Events

Alerte De Sécurité sur Vascu-Guard Peripheral Vascular Patch

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.

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
    2015-06-04
  • Date de publication de l'événement
    2015-06-04
  • 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_20150604a.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 vascu-guard peripheral vascular patch the united states food and drug administration (fda) has issued medical device safety alerts concerning vascu-guard peripheral vascular patch. the affected devices are identified as follow:- model numbers: 1504026 vascu-guard ts 1x6cm 1504028 vascu-guard ts 0.8x8cm 1504030 vascu-guard ts 1x10cm 1504032 vascu-guard ts 2x9cm the manufacturer received customer complaints of difficulty in distinguishing the smooth from rough surface of the vascu-guard patch as described in the instructions for use. this is due to a deviation in the surface texture of the vascular patch in a new packaging configuration. the manufacturer is recalling above product codes of its vascu-guard peripheral vascular patch. users can still order this product presented in a plastic jar filled with sterile water and 1% propylene oxide, such configuration is unaffected by this recall. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm449592.Htm http://www.Fda.Gov/safety/recalls/ucm449477.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 june 2015.

Device

Vascu-Guard Peripheral Vascular Patch
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Baxter Vascu-Guard Peripheral Vascular Patch
  • Manufacturer
    Baxter

Manufacturer

Baxter