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UK Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

Jan 23, 2015

Medical device maker Smith & Nephew has recalled its Renasys negative pressure wound care systems in the UK because of the risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds if there is a blockage in the vacuum system. The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s health regulatory agency, announced the recall.

The MHRA describes the negative pressure wound therapy (NPWT) device as an electric pump system that applies a vacuum to chronic, deep cavity wounds. Disposable components such as foam or gauze dressings and tubing are used with the device. But if an undetected blockage develops in the system, fluid from the wound can build up and leak from the dressing. The affected devices may not detect blockages and will not sound an alarm even if the dressing has visibly lifted from the wound.

The devices covered in the recall are the Renasys Go, Renasys EZ, Renasys EZ Plus, and Renasys EZ Max.

Smith & Nephew has amended the instructions for the use of the systems and advises all users to make themselves aware of the changes. This includes hospital and nursing home staff and those who care for patients’ wounds at home. The company stresses the importance of frequent checking of the wound and frequent checking of the device to be sure it is working properly. Users in the UK may contact a local Smith & Nephew representative to arrange for replacement devices.

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