Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing

10 Jan 2013

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Mentor Breast Implant, Winged Infusion Sets, and PSI‐TEC Tubing , manufactured by Mentor Medical Systems B.V.

The manufacturer has identified an issue where some lots of these products were inadvertently shipped out beyond their expiration date because of a scanning error in the company's inventory and distribution system.

Some of the lots may contain a secondary inventory label with an incorrect expiry date (different from the product label).

To date, no complaints have been reported that are connected to this issue.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON216883

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

Posted on 10 January 2013

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