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False CE Marking on Syringe

Notice type: Warning

Date: 21/03/2002

  

Product name or type:
False CE Marking on Syringe

Reference:
SN2002(01)

Target Audience:
Department of Health & Children; Chief Executive Officers - Irish Health Boards; Chief Executive Officers - Irish Hospitals; Pharmacists; Purchasing Managers; Drug Treatment Centres

Problem Or Issue:
R-D Ject Syringe  - A device with a false CE mark

Background Information Or Related Documents:
We have been advised by the Spanish Competent Authority that a manufacturer has been making syringes 2-pieces with a package and labelling similar to a Becton Dickinson product.   

The Becton Dickinson product “B-D Discardit II” has a label B-DR DIDCARDTM II, Becton Dickinson S.A., manufactured in FRAGA (HUESCA) ESPANA.   

The brand name of the similar product is “R-D ject FRAGE SPAIN” and they carry a false CE 0318 marking.   

It would appear that the “R-D ject” syringes are being sold in Africa.   

To date, the Spanish Competent Authority is not aware of the product being sold in Europe. 

False CE Marking on Syringe Document

Actions To Be Taken:
Please ensure that those responsible for the purchase of syringes are made aware of this issue. 

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

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

If you have any enquiries, you may contact the Medical Devices Department at: 

Telephone:    +353 1 6764971 
Fax:              +353 1 6767836 
Email:           vigilance@imb.ie
Website:       www.hpra.ie

SN2002(01): False CE Marking on Syringe

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