The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device alert concerning neonatal endotracheal tube SCP clamp/holder manufactured by Capatex Medical. The manufacturer is recalling the products prior to batch 1002854.
According to the MHRA, a change was made to the composition of the plastic material used, to make the clamps/holder DEHP-free. This affected the physical properties of the clamps, resulting in an increased risk of slippage. To counteract this, Capatex added an extra notch on the clamp. However, this introduced the possibility of over-tightening and occlusion of the internal diameter of the endotracheal tube. As a result, there is a risk of airway loss due to slippage or airway obstruction.
The manufacturer recommended that checks must be made to ensure the endotracheal tube is not slipping or being compressed.
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 25 May 2012