The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning nFlow Infant Nasal CPAP Breathing System, manufactured by Intersurgical. The affected REF numbers were 4700000, 4700001, 4700003, 4700004, 4700006, 4700007, 4700008, 4700009, 4700010, 4700014, 4700016, 4700017, 4700020, 4700150, 4760000 and 4761000. The affected LOT numbers were from 31400042 till 31458271.
There is a small possibility that the inspiratory tube or monitoring line tube may detach from the nFlow generator. This will result in loss of ventilation or its monitoring.
The manufacturer advises affected users to quarantine and destroy the above lot numbers. Alternatively if the products are required urgently, users are advised to inspect the product to make sure there is a noticeable amount of glue where the tube goes into the generator (patient end connector). Furthermore, users are advised to monitor the system continuously during use.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON462307
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 14 October 2014