Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) issued a medical device alert concerning Protect-A-Line IV extension set (supplied with vented caps) manufactured by Vygon. The affected product code is 0832.04 and all batch numbers ending in the letters BA are affected.

According to the MHRA, there is a risk of air embolus because the affected devices have been supplied with vented caps on the female port (Y-site) instead of non-vented caps.

• Identify affected devices.
• Prior to use, remove vented caps from the female port (Y-site) of affected devices and replace them with non-vented caps (or a needle free connector) if this port is to remain unused when the set is connected to a patient.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON306143

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 20 August 2013