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Aquilon series of nebulisers - Priority 1 - For Immediate Action

Notice type: For Immediate Action

Date: 29/05/2018

Product name or type:
Aquilon series of nebulisers

Reference:
MS35752

Target Audience:
Hospital Managers / CEOs
Risk Managers
Pharmacists
Paediatricians
Community nurses
Purchasing Managers
Stores / Supplies Managers
General Practicioners

Problem Or Issue:

The HPRA has been informed that the Aquilon series of nebulisers have been placed on the European market without appropriate CE certification. As such their safety and performance cannot be assured.
This safety notice is to alert users and healthcare professionals not to use these devices.

Background Information Or Related Documents:
The HPRA has been informed by another EU regulatory authority that CE marking for the Aquilon series of nebulisers manufactured by AFP Medical has been withdrawn. We have been unable to determine if affected devices have been placed on the Irish market, and are issuing this Safety Notice as a precaution.
Devices affected are the Aquilon 2, Aquilon, Aquilon+ and Aquilon Pro series manufactured since April 2015 (AL1, AL7, HO2, H51). Based on the information available it would appear that the manufacturer AFP Medical are no longer trading.
This safety notice is to alert users and health care professionals to examine their stock and stop using any affected medical devices identified

Actions To Be Taken:
The HPRA advises that users and healthcare professionals:
1. Examine your stock to determine if you have the affected devices.
2. Identify patients who may have the devices.
3. Stop using the device immediately and use an alternative nebuliser.
4. Forward a copy of this safety notice to all relevant personnel within your organisation or to any other organisations/persons to which/whom these devices have been transferred.
5. Report any adverse events/incidents associated with these devices to the manufacturer and the HPRA.

Further Information:

Please click here to view this Safety Notice

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