Archive for February 15th, 2010
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Zyprexa (olanzapine): Use in Adolescents
Clinicians should consider the potential long-term risks when prescribing to adolescents.
Videx/Videx EC (didanosine): Labeling Revision – Risk of Non-Cirrhotic Portal Hypertension
Risk information added to Warnings/Precautions section and data summary provided
Edwards Lifesciences Aquarius Hemodialysis System: Recall
Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.
Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.
Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall
Class I recall due to “coring” or dislodging of silicone cores or slivers from the ports into which they are inserted.
Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
BD Q-Syte Luer Access Devices: Recall
Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
Device may not be able to deliver therapy during a cardiac resuscitation attempt.
Tysabri (Natalizumab): Update of Healthcare Professional Information
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
