UK MHRA has issued a Medical Devices Alert on the Venturi 24%, 35% and 60% Air Entrainment Jet Adapters supplied in kits with Oxygen facemasks and Tubing, manufactured by Lifecare Hospital Supplies Ltd, following identification of the potential for full or partial blockage of the Venturi Oxygen Outlet.
The manufacturer issued a Field Safety Notice in September, but has not receieved enough confirmations from customers that they have received and acted on the information. Consequently this MDA has been issued.
Action is required by all staff involved in the provision of oxygen therapy and stores personnel.
This post is extracted from the full MDA, which should be consulted and can be found here.
Source: MHRA
published: November 9, 2011 in: Alerts/Adverse Events, News, Regulatory, Thoracic/Respiratory