What's New

• 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. Posted 03/11/2010
• 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. Posted 03/11/2010
• 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. Posted 03/11/2010
• Abiomed AB5000 Circulatory Support System: Class I Recall 
  Device computer may shut down without an alarm, which can lead to serious injuries or death. Posted 03/10/2010
• 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. Posted 03/10/2010
• 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. Posted 03/05/2010
• FDA Patient Safety News Video Broadcasts 
  March 2010 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. (Posted 03/04/2010)
• 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. Posted 03/03/2010
• 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. Posted 02/26/2010
• StatSpin Express 4 Centrifuges Model 510: Class I Recall 
  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. Posted 02/26/2010