What's New
Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators
Update to the July and October, 2005, Preliminary Public Health Notification. The updated PPHN provides numbers of deaths and serious injuries for the three devices as of December 12, 2005. FDA's recommendations have not changed.
(Posted 12/29/2005)
Fraudulent Avian Flu Therapies - Warning letters issued to nine companies marketing bogus flu products with claims that their products could be effective against preventing the avian flu or other forms of influenza.
(Posted 12/29/2005)
Vapotherm 2000i Respiratory Gas Administration Device - Update of safety information about Ralstonia spp. associated with Vapotherm Respiratory Gas Administration Device.
(Posted 12/20/2005)
Endologix Powerlink Delivery Catheters - Voluntary recall of selected Powerlink System delivery catheters as a result of an analysis of three recent reports of tip separation from the catheter sheath inner core during procedures.
(Posted 12/20/2005)
NeutroSpec (Technetium [99m Tc] fanolesomab) - Voluntary suspension of marketing effective immediately due to serious safety concerns. NeutroSpec is indicated for radiologic imaging of patients with unclear signs and symptoms of appendicitis who are five years of age and older.
(Posted 12/19/2005)
Baxter Meridian Hemodialyis (HD) Instrument - Reports of hemolysis related to kinks in the blood tubing sets. The clinical implication of returning hemolyzed blood to a patient can range from no adverse health consequences up to and including death.
(Posted 12/14/2005)
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