Events

Alerte De Sécurité sur ENDOPATH Probe Plus ll Shafts

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

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
    2013-04-26
  • Date de publication de l'événement
    2013-04-26
  • 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_20130426b.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: ethicon endopath probe plus ll shafts medical device manufacturer, ethicon, has issued a field safety notice concerning endopath probe plus ll shafts. the affected code numbers are eps01-eps08 (with expiration dates from september 2015 through and including march 2018) and eps10-eps13 (with expiration dates from april 2013 through and including march 2018). the manufacturer is initiating a voluntary recall for endopath probe plus ll shafts because the possibility that a tear in the tyvek packaging may compromise the sterility of the device such that we could no longer assure the stated sterility levels are met for our product. the endopath probe plus ll shaft is sold and labeled as “sterile”. this voluntary recall does not apply to the endopath probe plus ii handles. product recall is on-going. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

ENDOPATH Probe Plus ll Shafts
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ethicon ENDOPATH Probe Plus ll Shafts
  • Manufacturer
    Ethicon

Manufacturer

Ethicon