Events

Safety Alert for Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Sorin.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-11-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111115d.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sorin CRM Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)
  • Manufacturer
    Sorin

Manufacturer

Sorin