A Video News Show for Health Professionals. New broadcasts monthly, with online video and transcripts. http://www.fda.gov/psn/ en-us Sun, 01 Nov 2009 03:00:00 GMT psnews@cdrh.fda.gov http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/rsslogo.gif http://www.fda.gov/psn/ FDA has approved four vaccines for immunization against the 2009 H1N1 influenza virus. Three of them are inactivated virus vaccines for injection, manufactured by CSL Limited, Sanofi Pasteur, Inc, and Novartis Vaccines and Diagnostics Limited. The ... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#1 Covidien is recalling certain lots of its End-Tidal CO2 Detectors, the Pedi-Cap and Pedi-Cap 6, because a modification made by the manufacturer may occlude the patient's airway. This could make it difficult to manually ventilate a patient, and lead ... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#2 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#2 Tibotec Therapeutics is notifying healthcare professionals of severe and potentially life-threatening skin reactions from Intelence (etravirine), an antiretroviral drug used in HIV combination therapy. Intelence has been associated with cases of Ste... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#3 Boston Scientific has changed the name of the company's Liberté Bare-Metal coronary stent to VeriFLEX. The company took this action after reports that Liberté Bare-Metal stents were inadvertently implanted instead of TAXUS Liberté Drug-Eluting stent... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#4 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#4 Philips Healthcare has alerted healthcare professionals about the possibility of inaccurate fetal heart rate readings from the company's Avalon fetal monitors, which use ultrasound to measure fetal heart rate. Inaccurate readings could result in unn... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#5 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#5 Healthcare professionals have been notified by the manufacturers of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) that these drugs, in combination with other immunosuppressive agents, have been associated with cases of pure red ce... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#6 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#6 The device company ConMed Linvatec is recalling certain surgical handpieces and cables. The handpieces are battery-powered devices used with drills, blades and other cutting devices during surgical procedures. This action affects certain model an... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#7 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#7 FDA is requiring stronger warnings about an increased risk of lymphoma and other cancers in children and adolescents who are treated with drugs that block tumor necrosis factor. TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humir... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#8 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#8 Smiths Medical is recalling certain Portex uncuffed tracheal tubes in pediatric sizes. The recall affects several models of 2.5, 3.0 and 3.5 mm tubes manufactured before September 2009. The internal diameter of some of these tracheal tubes is sli... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#9 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#9 Emergency response help buttons are often worn by seniors to call for help in an emergency. The Philips Lifeline emergency button that is worn around the neck, may pose a choking hazard if the cord becomes accidentally entangled, and this can result... Sun, 01 Nov 2009 03:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#10 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#10