Events

Alerte De Sécurité sur Radius Loop Electrode Box of 5

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

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
    2014-10-31
  • Date de publication de l'événement
    2014-10-31
  • 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_20141031.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: coopersurgical radius loop electrode box of 5 medical device manufacturer, coopersurgical, has issued a field safety notice concerning its radius loop electrode box of 5. the affected part number is r2010 and lot number is 159621. the product may have been packaged with an incorrectly labeled package type (radius loop electrode p/n r1010). the affected product is a single-use sterile disposable device. the product package contains 5 individually sealed pouches consisting of clear plastic front and a tyvek lid back. the device lot number and expiration date is located on the tyvek lid as well as on the side of the external packaging. according to the manufacturer’s health hazard evaluation report, the potential hazard situation associated with the nonconformance is minimal and no adverse events or injuries have been reported to date in connection with the use of the affected product. the manufacturer advises customers to return the affected products to them and product replacement can be arranged. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 october 2014.

Device

Radius Loop Electrode Box of 5
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: CooperSurgical Radius Loop Electrode Box of 5
  • Manufacturer
    CooperSurgical

Manufacturer

CooperSurgical