Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom, has posted a medical device safety alert concerning Medset CM Breast Pump Kit, manufactured by Medela AG [Product Code: 001.0112 Medset CM; All lots]

An internal review performed by the manufacturer found that the labelling documentation for the Medset CM Breast Pump Kit is incomplete. Additionally, although all product is sterile, the manufacturer cannot demonstrate full compliance with the quality standard for sterilisation.

According to the manufacturer, no other sterile Breast Pump Kit is affected by this issue. It can confirm that, to date, there have not been any complaints received which are associated with this issue. However, the manufacturing of this product has been discontinued. A replacement product is immediately available.

The affected users are advised to:

• Immediately check their internal inventory and storage areas for subject devices;
• Transfer any subject devices which are found to quarantine area, pending destruction;
• Destroy all subject devices by removing from packaging and disposing in waste in accordance with any local or environmental regulations; and
• Notify the manufacturer immediately of any complaints associated with this issue.

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

Posted on 9 May 2018