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Latest Medical Device News

• Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall - Potential For Balloon To Not Deflate Or To Deflate To Slowly - Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient.
• Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication - Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes.
• Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient - The counterfeit product may have resulted in patients not receiving needed therapy.
• Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates - Risk of embolization/infarction to organs and potential organ complications.
• Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots - Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.
• Brilliant Blue G Compounded by Franck's: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases - [UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.
• Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms - Revised drug label clarifying dosing and warning recommendations.
• Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians - [UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.
• Gerber Good Start Gentle Powdered Infant Formula: Recall - Off-Odor - Reports of gastrointestinal complaints.
• Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose - UPDATED 05/14/2012. New recommendations for monitoring patients, and new contraindications, and dosing & administration information for use in certain patients.
• Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume - An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.
• Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume - Consequences of opioid pain medication overdose can be life-threatening, including respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.
• Other‐Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination - Exposure to contaminated product may lead to serious infections.
• Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies - UPDATED 05/07/2012. Increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma in patients being treated with Revlimid.
• Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result - Customers should immediately discontinue use of any affected product.
• Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury - Products with this toxic metal have been found in at least seven states, are manufactured abroad and often sold in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.
• Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform - May result in reduction of blood flow from the pump, pump/graft thrombosis, or perforation of the outflow graft.
• Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions - UPDATED 04/26/2012. Label revised to state that co-administration of Victrelis with certain ritonavir-boosted human immunodeficiency virus protease inhibitors is not recommended. Originally posted 02/09/2012
• X-Rock: Recall - Undeclared Drug Ingredient - Undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.
• Zithromax (azithromycin): FDA Statement on risk of cardiovascular death - A retrospective cohort study reports small increase in risk of cardiovascular deaths and risk of all cause deaths associated with 5 day course of antibiotic drug