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Latest Medical Device News

• Abiomed AB5000 Circulatory Support System: Class I Recall - Device computer may shut down without an alarm, which can lead to serious injuries or death.
• Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety - FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
• 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.
• 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.
• 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.
• Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall - Defective devices may result in air bubbles leaking into the infusion system and into the patient’s bloodstream.
• Cleviprex (clevidipine butyrate): Recall - The recall of 12/2009 has been expanded to include four additional lots. Presence of particulate matter which could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.
• Counterfeit Polypropylene Surgical Mesh: Initial Communication - Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.
• Ear Candles: Risk of Serious Injuries - Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.
• Exjade (deferasirox): Boxed Warning - Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
• Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall - Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized.
• Invirase (saquinavir): Ongoing safety review of clinical trial data - Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
• Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements - FDA requires risk management plan and class-labeling changes for all LABAs.
• 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.
• 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.
• Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug - Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers.
• 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.
• Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall - Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.
• 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.
• 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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