Food and Drug Adminstration (FDA): MedWatch

Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall

03/11/2010 02:45 PM
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.

Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures

03/11/2010 10:15 AM
FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.

Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall

03/11/2010 08:15 AM
Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.

Abiomed AB5000 Circulatory Support System: Class I Recall

03/10/2010 03:20 PM
Device computer may shut down without an alarm, which can lead to serious injuries or death.

WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis

03/10/2010 11:50 AM
Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall

03/08/2010 01:15 PM
UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010

Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall

03/05/2010 11:20 AM
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.

Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall

03/03/2010 10:55 AM
Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.

OneTouch SureStep Test Strips (LifeScan): Recall

02/26/2010 04:05 PM
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

StatSpin Express 4 Centrifuges Model 510: Class I Recall

02/26/2010 01:05 PM
Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.

Invirase (saquinavir): Ongoing safety review of clinical trial data

02/23/2010 12:32 PM
Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).

Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety

02/22/2010 02:00 PM
FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.

Ear Candles: Risk of Serious Injuries

02/20/2010 03:15 PM
Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.

Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements

02/18/2010 02:20 PM
FDA requires risk management plan and class-labeling changes for all LABAs.

Exjade (deferasirox): Boxed Warning

02/18/2010 07:55 AM
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.

Maalox Total Relief and Maalox Liquid Products: Medication Use Errors

02/17/2010 06:30 PM
Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication

02/16/2010 09:55 AM
FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.

BD Q-Syte Luer Access Devices: Recall

02/09/2010 05:00 PM
Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.

Tysabri (Natalizumab): Update of Healthcare Professional Information

02/05/2010 10:00 AM
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical

02/04/2010 01:40 PM
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.

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