Medoject sterile hypodermic and blunt fill needles manufactured by Chirana T. Injecta – discontinue use (DSI/2021/003) - GOV.UK

2022-05-28 14:24:23 By : Mr. Chris Lee

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There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles

Some users of these needles have seen a black residue on the surface. The manufacturer issued a Field Safety Notice (FSN) recalling the 5 batches reported.

Further investigation by the MHRA has since revealed that the specific root cause of this issue is unknown, and it may affect all batches of the Medoject hypodermic and blunt fill needles.

Since the FSN was released, the black residue has been identified as amorphous carbon. The information currently available to the manufacturer suggests that the risk of harm to patients is low. There is a large number of alternative devices available on the UK market. Therefore, because the specific root cause of the problem is undetermined, the MHRA is advising the following actions:

Identify all Medoject hypodermic and blunt fill needles in your organisation

Stop using these needles and dispose of them

Share this information with all those who may also have affected products

Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

If you have any queries about this information, please contact:

Chirana T.Injecta Rastislav.Broska@t-injecta.sk +421 910 955 937

aic@mhra.gov.uk quoting MHRA ref: 2020/010/001/487/002

Don’t include personal or financial information like your National Insurance number or credit card details.

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