From the category archives:

MedWatch

Baylis Medical Company Torflex Transseptal Guiding Sheath: Class I Recall

March 11, 2010

Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
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Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures

March 11, 2010

FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
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Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall

March 11, 2010

Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
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Abiomed AB5000 Circulatory Support System: Class I Recall

March 10, 2010

Device computer may shut down without an alarm, which can lead to serious injuries or death.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
View Full Details Of The Original MedWatch Notice Here.

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

March 10, 2010

Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
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Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall

March 8, 2010

UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
View Full Details Of The Original MedWatch Notice Here.

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

March 5, 2010

Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
View Full Details Of The Original [...]

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

March 3, 2010

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.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
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OneTouch SureStep Test Strips (LifeScan): Recall

February 26, 2010

Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
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StatSpin Express 4 Centrifuges Model 510: Recall

February 26, 2010

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.
This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.
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