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‘First Steps’ Medicine Feeder

Notice type: Recall

Date: 18/06/2009

  

Product name or type:
‘First Steps’ Medicine Feeder

Reference:
IMB Safety Notice: SN2009(05)

Manufacturer Or Supplier:
RSW International Limited, United Kingdom.

Target Audience:
General public 
Pharmacies 
Retailers

Problem Or Issue:
Non-compliant ‘First Steps’ medicine feeders have been provided to retail outlets in Ireland by RSW International Limited. These medicine feeders are not appropriately CE marked.

Background Information Or Related Documents:
The IMB is advising that non-compliant ‘First Steps’ medicine feeders have been provided to retail outlets in Ireland, including a number of discount retail outlets. These medical devices may also be available for sale on the internet. 

These medicine feeders are marketed for the administration of liquid medicines to babies and young children. As they are not CE marked, it cannot be guaranteed that these products have been manufactured to the appropriate standards. 

To date, there have been no incidents reported to the IMB in relation to the use of this device within Ireland. As a precautionary measure, as there is a potential for administration of incorrect dosage, the IMB advises all consumers to stop using ‘First Steps’ medicine feeders.

‘First Steps’ Medicine Feeder Document

Actions To Be Taken:
Advice for Pharmacies, Retailers and Wholesalers
Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices from the ‘First Steps’ medicine feeder range. 

If you find that you have these products, cease sale of these products immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance. 

Also, should you discover any other similar brands of medicine feeders that do not carry the CE mark, please advise the IMB.

Advice for Consumers 
Consumers should check their medicine feeders to determine if their device is branded ‘First Steps’ medicine feeder range. 

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:
All adverse incidents relating to a medical device should be reported to the: 

Human Products Safety Monitoring Department 
Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: medsafety@hpra.ie
Website: www.hpra.ie 

Enquiries to the manufacturer should be addressed to: 

Mr. David Beaumount 
RSW International Limited, 
Unit 4 Cowm Top Business Park 
Cowm Top Lane 
Rochdale OL11 2PU 
United Kingdom 

Telephone: +44-845-226-8311 
Fax.           +44-845-226-8322

IMB Safety Notice: SN2009(05)

SAMPLES OF THE ’FIRST STEPS’ FEEDER RANGE

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