Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall
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Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Baylis Medical Company Torflex Transseptal Guiding Sheath: Class I Recall
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
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
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
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
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
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
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
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
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.