Davis's Drug Guide : FDA Safety Information and Adverse Event Reporting

FDA Safety Information and Adverse Event Reporting
Abiomed AB5000 Circulatory Support System: Class I Recall
WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall
Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
OneTouch SureStep Test Strips (LifeScan): Recall
StatSpin Express 4 Centrifuges Model 510: Class I Recall
Invirase (saquinavir): Ongoing safety review of clinical trial data
Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
Ear Candles: Risk of Serious Injuries
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
Exjade (deferasirox): Boxed Warning
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
BD Q-Syte Luer Access Devices: Recall
Tysabri (Natalizumab): Update of Healthcare Professional Information
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Zyprexa (olanzapine): Use in Adolescents
Videx Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Edwards Lifesciences Aquarius Hemodialysis System: Recall

FDA Safety Information and Adverse Event Reporting

Abiomed AB5000 Circulatory Support System: Class I Recall

Description

March 10, 2010
Device computer may shut down without an alarm, which can lead to serious injuries or death.
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