The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device safety alert concerning all neonatal and paediatric endotracheal tube clamp/holder manufactured by EMS Medical.
According the MHRA, the composition of the plastic used to make the clamp/holder was changed to a DEHP-free material. This affected the physical properties of these components, resulting in an increased risk of slippage or tube obstruction.
Based on the information provided by the MHRA, EMS Medical has gone into administration before this issue was identified and it is not known how many affected devices have been supplied.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/index.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 July 2012