Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Neptune 2 Ultra Waste Management System, manufactured by Stryker. Details of affected products are as follows:

• Catalogue no.: 0702-001-000, 0702-002-000, 0700-001-000, 0700-002-000, 0700-003-000, 0700-007-000
• Lot no.: All

The manufacturer has received four serious complaints where it was determined that the Neptune Rover had been connected to a passive chest drainage tube post-operatively resulting in patient haemorrhage.

Furthermore, the manufacturer advises users of the followings:

• Quarantine the affected products until Stryker is able to provide upgrades to units.
• Ensure that the above mentioned devices are not used and alternative methods of suction should be sought.
• Quarantined devices are recommended to undergo decontamination by a Stryker Field Service Representative to ensure there is no standing water or fluid left in the devices while they are in quarantine.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON355483

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

Posted on 24 December 2013