> [Original Message] > From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]> > To: <[EMAIL PROTECTED]> > Date: 3/27/2007 9:26:39 PM > Subject: 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 > > _________________________________________________________________ > > To ensure delivery of these timely alerts to your in-box and prevent rejection of the notice by a spam filter, please add our MedWatch address, [EMAIL PROTECTED], to your address book. > > Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process. They can learn more and subscribe to the e-list at http://www.fda.gov/medwatch. > > To send a comment or question to the MedWatch program: http://www.fda.gov/medwatch/feedback.htm > > To unsubscribe from this listserve: > https://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1
