Archive | March, 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.
Continue reading...WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
10. March 2010
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Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
Continue reading...Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall
8. March 2010
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UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
Continue reading...Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
5. March 2010
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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.
Continue reading...Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
3. March 2010
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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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10. March 2010
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