ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Dropper
Notice type: Advisory
Date: 01/06/2011
Product name or type:
ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Droppe
Reference:
SN2011(10)
Manufacturer Or Supplier:
Manufacturer: Health Enterprises Inc., USA
Target Audience:
General public
Pharmacies
Problem Or Issue:
Non-compliant ACU-LIFE dosage spoons and ACU-LIFE dosage droppers have been provided to pharmacy outlets in Ireland. These dosage spoons and dosage droppers are not appropriately CE marked. Although they carry the CE mark, the CE mark is not accompanied by a four digit Notified Body number, which confirms that the measuring function aspect of the medical device has been reviewed and certified by a Notified Body, as required by the medical devices legislation.
Background Information Or Related Documents:
The Irish Medicines Board (IMB) is advising that non-compliant ACU-LIFE dosage spoons and ACU-LIFE dosage droppers have been provided to pharmacy outlets in Ireland.
These medicine feeders are marketed for the administration of liquid medicines. As they are not appropriately CE marked, it cannot be guaranteed that these products have been manufactured to the appropriate standards and therefore may not reach the required standards of safety and quality, as required by the European medical device legislation.
To date, there have been no incidents reported to the IMB in relation to the use of these medical devices within Ireland. As a precautionary measure, the IMB advises all consumers to stop using ACU-LIFE dosage spoons and ACU-LIFE dosage droppers.
Actions To Be Taken:
Advice for Pharmacies
Pharmacies and retailers should examine their stock to determine if they have any ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.
If you find that you have these products, cease sale of these products immediately and quarantine all stock and contact Atlantico Systems immediately to obtain further instruction and guidance.
Please advise the IMB should you discover any other similar brands of dosage spoons, dosage droppers or medicines feeders that:
(a) Do not carry the CE mark
(b) Carries a CE mark but the CE mark is not accompanied by a four digit Notified Body number
Advice for Consumers
Consumers should check their dosage spoons and/or dosage droppers to determine if their device is branded ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.
If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.
Further Information:
Atlantico Systems are co-ordinating this product removal in Ireland on behalf of Health Enterprises Inc. Enquiries should be addressed to:
Dr. Natasha Forde
Atlantico Systems
34 Oldfield
Kingston
Galway
Telephone: 091-443609
Email: info@atlanticosystems.com
Mr. Brooke Fishback
Health Enterprises Inc.
90 George Leven Drive
North Attleboro
MA 02760, USA
Telephone: +1-508-695-0727
Email: bfishback@healthenterprises.com
All adverse incidents relating to a medical device should be reported to the:
Human Products Monitoring
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
Website: www.hpra.ie
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