Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Medtronic Sutureless Connector Intrathecal Catheter

19 Jun 2013

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Sutureless Connector Intrathecal Catheter, manufactured by Medtronic. The affected products have model numbers of 8709SC, 8731SC, 8596SC and 8578, and a Use By Date prior to 25 August 2014.

The Sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing unused products from the market that were manufactured with the previous design, and recommends the previous design no longer be used due to greater potential for misalignment and subsequent occlusion. Replacement of current design products is also available.

According to the local supplier, the affected products were not distributed in Hong Kong.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON286830

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 19 June 2013

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