Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Covidien Monojectâ„¢ Insulin Safety Syringe

12 Jun 2012

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Monoject™ Insulin Safety Syringe, manufactured by Covidien.

The manufacturer is conducting a field safety corrective action (FSCA) regarding specific lots of Monoject™ Insulin Safety Syringe with a volume of 3/10 and 1/2 ml. This FSCA is being conducted due to a molding issue that can allow the safety shield to separate from the syringe, exposing the needle, which could potentially result in a needle stick.

According to the local supplier, the affected products were not distributed in Hong Kong.

For details, please refer to the following MHRA website: 
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm

If you are in possession of the product, please contact your supplier for necessary actions.

Posted 12 Jun 2012

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