UK Competent Authority on Medical Devices, the MHRA has issued a medical device alert relating to Nottingham-based Capatex Medical’s Endotracheal tube clamps which it says may result in a risk of airway loss due to slippage or airway obstruction, as a result of over-tightening of the clamp/holder.
Capatex is recalling affected products and has advised users of the issue in Field Safety Notices which can be found here. The MHRA is issuing a Medical Device Alert to reinforce the manufacturer’s actions.
The alert pertains to the following items:
Neonatal endotracheal tube SCP clamp/holder.
CM – SCP020 – ENDO
CM – SCP025 – ENDO
CM – SCP030 – ENDO
CM – SCP035 – ENDO
CM – SCP040 – ENDO
(Lot numbers up to and including 1002853)
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.
All clamps from lot number 1002854 onwards have been manufactured using a new material.
Customers are asked to identify and quarantine affected devices prior to return to Capatex Medical for exchange.
The company helpfully points us to www.capatexmedical.com, a site which has not been populated. Contact therefore email@example.com