Field Safety Notice Philips Respironics Humidifiers Updated Instructions for Use (ICN 2302)

Alert:

• Philips Respironics has issued an Important Product Notice 2022-CC-SRC-056 to advise they have updated the Instructions for Use for A40 Pro, BIPAP A40EFL, BIPAP A30 EFL and the System one humidifier cleaning, to remove Keredusy as a disinfection method.
• Keredusy has been removed as a disinfection method due to unknown long-term effects of this disinfection method on the device components.
• Philips Respironics advise the issue does not present any hazard/harm. No adverse events, including death or injuries have been reported.

Products Affected:

• Some of these products are available from NHS Supply Chain. See our Downloads ▼ section to access the product listing for further information on the affected product codes.
• Please note this is an update to the Instructions for Use, not a recall, the products listed are not to be returned.

Next Steps:                       

• Read and follow the full instructions in the Important Product Notice and updated User Manual Addendum and share with all users of the affected products.
• For further information or support concerning this issue, please contact our local Philips representative at the UK Philips Customer Care Service Centre on 0870 532 9741.
• Complete the Acknowledgement and Receipt Form on Page 4 of the Important Customer Notice and return by emailing safetynoticeuki@philips.com

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Please be aware that in the event of a Field Safety Notice or Product Recall, we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.