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FDA ALERT

Tuesday, 27 March 2007 18:00 Ramaz Mitaishvili

FDA ALERT March 28, 2007

FDA MedWatch - Smith & Nephew Radio Frequency (RF) Denervation Probes: class 1 nationwide recall due to mislabeling as sterile

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals of a nationwide Class I recall of RF Denervation probes used with the Smith & Nephew Electrothermal 20S Spine System in RF heat lesion procedures for the relief of pain. The product was mislabeled. The device is a non-sterile (not germ free) device but it was labeled incorrectly as sterile (germ-free). It is a reusable item that is intended to be sterilized (made germ-free) by the medical facility prior to each use, including initial use. This error may result in infections with associated risks including, organ failure and/or death.

Read the complete MedWatch 2007 Safety summary, including a link to the FDA recall notice and firm press release, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#RFprobes

Last Updated ( Monday, 11 February 2008 19:55 )

Emergency Preparedness and You

The possibility of public health emergencies arising in the United States concerns many people in the wake of recent hurricanes, tsunamis, acts of terrorism, and the threat of pandemic influenza. Though some people feel it is impossible to be prepared for unexpected events, the truth is that taking preparedness actions helps people deal with disasters of all sorts much more effectively when they do occur.

To help, Centers for Disease Control and Prevention (CDC) and the American Red Cross have teamed up to answer common questions and provide step by step guidance you can take now to protect you and your loved ones.

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