New Medical Products: Vaccines for 2009 H1N1 Influenza

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 ... (read more)

Recalls and Safety Alerts: Pedi-Cap End-Tidal CO2 Detectors Recalled

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 ... (read more)

Recalls and Safety Alerts: Life-Threatening Skin Reactions with Intelence

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... (read more)

Recalls and Safety Alerts: Liberte Coronary Stent Now Called VeriFLEX

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... (read more)

Recalls and Safety Alerts: Inaccurate Readings with Philips Avalon Fetal Monitors

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... (read more)

Recalls and Safety Alerts: Pure Red Cell Aplasia with CellCept and Myfortic

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... (read more)

Recalls and Safety Alerts: Recall of ConMed Linvatec Surgical Handpieces and Cables

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... (read more)

Recalls and Safety Alerts: TNF Blockers and Cancer in Children

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... (read more)

Recalls and Safety Alerts: Portex Uncuffed Pediatric Tracheal Tubes Recalled

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... (read more)