Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device alert concerning Coopers Walking frames, manufactured by Sunrise Medical. The affected products had dispatch dates from 20 August to 02 October 2012 inclusive. The affected product codes were 7321C, 7323C, 7325C, 7331C, 7333C, 7335C, 7341C, 7343C, 7351C and 7353C.

According to the manufacturer, there was risk of falls due to the walking frame becoming unstable. The rear screws that fasten the C-shaped lower bar to the frame may fail because of a manufacturing fault. The failure usually occurred a short time after assembly.

MHRA had the following advice:

• To identify affected devices and users should undertake a visual check of affected devices located in stores. All rear screws should be checked to ensure that they are present, not loose or broken.
• Devices that are found to have missing, broken or damaged screws are to be quarantined and not used.
• Users were advised to return damaged devices to the manufacturer for replacement or corrective action.

For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON213178

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

Posted on 7 December 2012