Events

Alerte De Sécurité sur Merit 7F Prelude Short Sheath Introducers

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

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
    2017-03-31
  • Date de publication de l'événement
    2017-03-31
  • 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_20170331.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: merit 7f prelude short sheath introducers the united states food and drug administration (fda) has issued a medical device safety alert concerning merit 7f prelude short sheath introducers [lot numbers: h1041469, h1041473, h1036880, h1041464; catalogue numbers: k15-00070, k15-00170, pss-7f-4-035mt, pss-7f-4mt; manufacturing dates: 23 nov 2016 to 30 nov 2016; distribution dates: 15 dec 2016 to 18 jan 2017], manufactured by merit medical systems, inc. the manufacturer is recalling the prelude short sheath introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure. if this occurs, the tip could enter the patient's bloodstream. this may result in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death. the manufacturer advises users to quarantine and discontinue use of the affected products and return them to the manufacturer. for details, please refer to the fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm549795.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 march 2017.

Device

Merit 7F Prelude Short Sheath Introducers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Merit 7F Prelude Short Sheath Introducers
  • Manufacturer
    Merit Medical Systems

Manufacturer

Merit Medical Systems