All Entries in the "Medical Products" Category
Xigris [drotrecogin alfa (activated)]: Market Withdrawal – Failure to Show Survival Benefit
In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.
Virility Max: Recall – Undeclared Drug Ingredient
Product marketed as dietary supplement contains sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
CooperVision Avaira Toric Soft Contact Lenses: Class 1 Recall- Unintended Residue on Lenses
Presence of a silicone oil residue on lenses from certain lots of my cause range of symptoms such as hazy, blurry vision, discomfort to eye injuries requiring medical treatment.
Chantix (varenicline)
UPDATED 10/24/2011. Updated study data. Healthcare professionals should continue to monitor patients for neuropsychiatric symptoms.
Mizuho OSI Modular Table Systems: Class I Recall – Reports of Patient Injury
Potential for patient falls or unanticipated patient movement, which may result in serious injury or death.
Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall
AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy, when used with an affected battery pack.
Proton Pump Inhibitors (PPI): Class Labeling Change
Possible increased risk of fractures of the hip, wrist, and spine.
Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease
Study terminated following the identification of an imbalance of thrombosis of the portal venous system in patients treated with eltrombopag versus matching placebo.
Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall
Flex tube may not fit securely within the endotracheal tube (ET) connector.
GE Healthcare Aisys and Avance Anesthesia Systems: Recall
Defective control board wiring harnesses can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
Baxter Colleague Infusion Pumps: FDA Ordering Recall
Action based on failure to correct serious problems with infusion pumps.
