Events

Alerte De Sécurité sur Covidien Curity All Purpose Gauze Sponges, Curity X-Ray Detectable Laparotomy Sponges, Kerlix X-Ray Detectable Laparotomy Sponges, Vistec X-Ray Detectable Sponges

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

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
    2016-03-22
  • Date de publication de l'événement
    2016-03-22
  • 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_20160322a.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: medtronic covidien curity all purpose gauze sponges, curity x-ray detectable laparotomy sponges, kerlix x-ray detectable laparotomy sponges, vistec x-ray detectable sponges the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning covidien curity all purpose gauze sponges, curity x-ray detectable laparotomy sponges, kerlix x-ray detectable laparotomy sponges, vistec x-ray detectable sponges manufactured by medtronic. the manufacturer is recalling specific item codes and production lots of the above products due to the potential for the sterile barrier to be compromised at the package seal. the use of products with this condition may result in a potentially increased risk for infection. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-14-march-to-18-march-2016 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 22 march 2016.

Device

Covidien Curity All Purpose Gauze Sponges, Curity X-Ray Detectable Laparotomy Sponges, Kerlix X-R...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Covidien Curity All Purpose Gauze Sponges, Curity X-Ray Detectable Laparotomy Sponges, Kerlix X-Ray Detectable Laparotomy Sponges, Vistec X-Ray Detectable Sponges
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH