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Lubby Baby New-Safe Medicine Feeder

Notice type: Recall

Date: 10/09/2003

  

Product name or type:
Lubby Baby New-Safe Medicine Feeder

Reference:
SN2003(06)

Manufacturer Or Supplier:
Manufactured by Freeda Moore, Taiwan. 
Distributed by Sundrelle Limited, Ashbourne, Co. Meath.

Target Audience:
Retail Pharmacies

Problem Or Issue:
  • The measuring function of the syringe and the beaker are not in concurrence, which could result in a higher administered dose than intended.
  • This product does not carry a CE mark.

Background Information Or Related Documents:
It has come to the attention of the Irish Medicines Board (IMB) that the Lubby New-Safe Medicine Feeder has been placed on the Irish market.  This product is classified as a medical device under the Medical Devices Directive 93/42/EEC, Article 1, 2(a) and the related S.I. No. 252 of 1994 European Communities (Medical Devices) Regulations, 1994.  It appears that this product does not carry a CE mark in line with the Legislation.  In order to place a medical device product on the Irish market the manufacturer / authorised representative is required to CE mark the product.   

There are also concerns over the safety of the use of this product as, after examination, it has been found that the measuring function of the syringe and the beaker are not in concurrence.  If the beaker is solely used for dispensing medication, the dose administered could be higher than intended.   

Resulting from the above, the IMB has requested the recall of this product to retail level.  The IMB has been advised that this product has been distributed to pharmacies by Sundrelle Limited, Ashbourne, Co. Meath.

Lubby Baby New-Safe Medicine Feeder Document

Actions To Be Taken:

The IMB advises that you:
 

  • Ensure that all relevant staff are advised of the potential problem with this product.
  • Cease selling this product.
  • Quarantine any units that you may have in your possession.  The quarantined stock should be returned to your distributor for disposal.
  • Report any indications of problems with the device to the IMB.  
Please advise the IMB of any stock that you have quarantined and returned.

Further Information:
If you have any enquiries relating to the above you may contact  the HPRA Medical Devices Department at:   

Medical Devices Department 
Health Products Regulatory Authority 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

Telephone:       +353-1-6764971 
Fax:                 +353-1-6767836
Email:               vigilance@imb.ie

SN2003(06): Lubby Baby New-Safe Medicine Feeder

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