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Monday 21st of May 2012

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Medical & Drug Recalls


Posted: 04:24 AM March 17th, 2010
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall Audience: Hospital risk managers [03/16/2010] Teleflex Incorporated notified healthcare professionals of the recall of all lots of Arrow Select IV Tubing Sets, accessories, and certain lots of arterial embolectomy catheters because it has been determined that product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged, and if product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death. Consumers who have products with the part numbers noted in the firm's press release should stop using and return the items to...
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Posted: 04:30 AM March 12th, 2010
Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug Audience: Cardiology healthcare professionals, patients [03/12/2010] FDA notified healthcare professionals and patients that a Boxed Warning has been added to the prescribing information for Plavix, an anti-blood clotting medication. The Boxed Warning in the drug label will include information to: Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body. Inform healthcare professionals that tests are available to identify genetic differences in CYP2C19 function. Advise healthcare...
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Posted: 04:30 AM March 12th, 2010
Counterfeit Polypropylene Surgical Mesh: Initial Communication Audience: Surgical services managers, risk managers [03/12/2010] Counterfeit flat sheets of polypropylene surgical mesh, used in the repair of hernias and chest wall defects, are being marketed in the United States, labeled with the C. R. Bard/Davol brand name. These products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturersâ polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit. The product codes, sizes and lot numbers of the counterfeit product identified, to date, are noted in the linked Initial Communication...
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Posted: 02:13 AM March 11th, 2010
Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures Audience: Orthopedic healthcare professionals, patients [03/11/2010] FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further. FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral...
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Posted: 02:13 AM March 11th, 2010
Beckman Coulter UniCel DxC Synchron Clinical System â" Ion Selective Electrode Flow Cell: Class I Recall Audience: Hospital risk managers, laboratory managers [03/11/2010] FDA notified healthcare professionals of the Class I recall of UniCel DxC Synchron Clinical System â" Ion Selective Electrode (ISE) Flow Cell. These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. There may be excessive build-up of protein, bacteria, and sample tube additives in the instrumentâs ion selective electrode flow cell which may cause incorrect sodium results. This product has been...
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Posted: 06:58 AM March 10th, 2010
Abiomed AB5000 Circulatory Support System: Class I Recall Audience: Cardiovascular surgery healthcare professionals, hospital risk managers, biomedical engineers [03/10/2010] FDA notified healthcare professionals of the Class 1 recall of the AB5000 Circulatory Support System, a product that supplies power to disposable blood pumps used to support the left and/or right sides of the heart. The computer may shut down (stop pumping) without an alarm and this defect may cause serious injuries or death. These products were manufactured and distributed between May 2003 and December 2009. [03/10/2010]


Posted: 02:23 AM March 10th, 2010
WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis Audience: Hematological healthcare professionals [03/10/2010] Cangene, Baxter and FDA notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF. IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its...
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