Events

Alerte De Sécurité sur Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)

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

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
    2011-11-15
  • 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_20111115d.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
    Health canada type ii recall: sorincrm isoline 2cr6 defibrillation leads (serial no. s2cr605346 and s2cr605347) it has come to our attention that the health canada has issued a type ii recall regarding the sorincrm isoline 2cr6 defibrillation leads (serial no. s2cr605346 and s2cr605347). as stated in the report, a batch of isoline defibrillation leads was labelled with an incorrect use before date (ubd), which was greater than the maximum of 36 months shelf life. the date printed on the labels was 5 may 2013, while the correct ubd is 21 september 2012. according to the supplier, the affected product with serial no. s2cr605346 and s2cr605347 have never been distributed or supplied in hong kong. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2011-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Sorin CRM Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)
  • Manufacturer
    Sorin

Manufacturer

Sorin