Recall of Coloplast catheter valves amid sterility concerns

Published: 14-Mar-2012
Regulatory Medical Devices

Question mark over sterility leads to medical device warning


Medical device manufacturer, Coloplast, is recalling a range of catheter valves amid concerns over sterility.

A Medical Device Alert has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) concerning the equipment, which is sold as item number 380851

It comes after routine sterility tests failed and has led to a widespread recall of devices.

A statement from the company says: “Coloplast has not received any complaints and therefore no signals for safety concerns. It is assumed that the catheter valve is used in a non-sterile environment. Under this assumption the lack of sterility is very unlikely to affect the patient and user’s safety.”

However, it urging any organisations using the equipment to stop immediately and contact the firm for a replacement.

Click here to see the alert

  • Companies:
  • Coloplast
  • Medicines and Healthcare products Regulatory Agency
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