Important Safety Alerts

Important Safety Alerts

Health Canada Type II Recall: SorinCRM Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)

15 Nov 2011

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.

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