The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device, manufactured by Bedfont Scientific.
The manufacturer noticed that some operators of the NOxBOXi Nitric Oxide Delivery and Monitoring Device have been using components which have not been supplied or recommended by Bedfont Scientific.
The manufacturer has provided a list of possible components which are not supplied by Bedfont Scientific. in the field safety notice. These components included calibration gas, sample lines / disposables, manual bagging accessories and transportation accessories. According to the manufacturer, using such supplied parts may damage the device and cause injury or in some cases death to the patient or the operator.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON455982
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 23 September 2014