Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has posted a medical device safety alert concerning Single Use Home Ventilation Breathing Circuit, manufactured by Fisher & Paykel Healthcare. [Reference number: RT443; Lot numbers: From Lot 2100089390 to Lot 2100233760]

The manufacturer is initiating a voluntary recall of the products due to an increased rate of split tubing cuffs in catheter mounts manufactured on specific dates. A split tubing cuff on the catheter mount may potentially cause a leak, which could lead to patient hypoxaemia if undetected.

Users are advised to take the following actions:

• Identify any affected products in their inventory by checking the REF and LOT number on the packaging.
• For the affected products, disconnect the catheter mount component, cut this in half and then dispose the entire kit.

For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-16-to-20-october-2017

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

Posted on 27 October 2017