Baylis Medical 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.
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11. March 2010
Posted in: FDA Alerts and Warnings
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.
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11. March 2010
Posted in: FDA Alerts and Warnings
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.
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10. March 2010
Posted in: FDA Alerts and Warnings
Abiomed AB5000 Circulatory Support System: Class I Recall
Device computer may shut down without an alarm, which can lead to serious injuries or death.
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10. March 2010
Posted in: FDA Alerts and Warnings
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.
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8. March 2010
Posted in: FDA Alerts and Warnings
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
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5. March 2010
Posted in: FDA Alerts and Warnings
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.
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3. March 2010
Posted in: FDA Alerts and Warnings
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.
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26. February 2010
Posted in: FDA Alerts and Warnings
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.
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26. February 2010
Posted in: FDA Alerts and Warnings
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.
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11. March 2010
Posted in: FDA Alerts and Warnings