Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) is warning health care professionals, hospital personnel and patients that counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States and labeled with the C.R. Bard/Davol brand name. Four products have been identified to date as not being Bard-manufactured products. These products are used to reinforce soft tissue where weakness exists in the repair of hernias and chest wall defects.

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A weight loss dietary supplement is being recalled by the Food and Drug Administration (FDA) after an FDA analysis found the supplements contain the presence of undeclared drug ingredients, including a suspected cancer-causing agent. The recalled supplement is made by GMP Herbal Products and is marketed under the name Pai You Guo.

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Foreign particle contamination of several products used to treat rare, serious and life-threatening diseases has prompted a warning by the Food and Drug Administration (FDA). The warning includes products made by Genzyme and marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme and Thyrogen – used to treat serious conditions such as Gaucher Disease and thyroid cancer. The foreign particles found in the medications include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients.

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A device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration (FDA) because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or death to patients.

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A brand of the anesthetic propofol is being recalled by the Food and Drug Administration (FDA) because the injectable emulsion may contain particulate matter that could potentially impede blood flow and lead to serious health issues such as stroke, respiratory failure, kidney failure, liver failure, heart attack and/or stroke. The recall includes 85 lots of Hospira, Inc. brand Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July 2009 and October 2009.

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All lots and expiration dates of 65 BodyBuilding.com brand dietary supplements are being recalled because the Food and Drug Administration (FDA) believes the products contain ingredients that are either classified or the FDA believes they should be classified as steroids. Acute liver injury is known to be a possible harmful effect of using steroid-containing products.

Steroids also may cause other serious long-term adverse health consequences including shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

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Pointe Scientific, Inc., is recalling all size kits of its Liquid Glucose Hexokinase Reagent catalog number G7517, after the reagents were found to fail linearity at the >200 mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Pointe Scientific, Inc., Liquid Glucose Hexokinase Reagent (G7517) should destroy the remaining inventory.

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A sheath used to deliver therapeutic or diagnostic intravascular devices or fluids through the skin is being recalled by the distributor as a result of complaints about stretching or fracture of the sheath during use which have lead to patient injury, according to an announcement by the Food and Drug Administration (FDA).

The nationwide recall includes all lots of the CROSSOVER Sheath Introducer, a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous, or through the skin, introduction of therapeutic or diagnostic intravascular devices or fluids.

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The Food and Drug Administration (FDA) is investigating certain types of medical devices made by Hospira Inc. and Abbott Nutrition after 122 reports of sparking, charring and fires from the power cords used with the devices. The announcement follows a recall announcement and FDA warning last August on some medical devices made by Hospira Inc. because of faulty electrical cords that could lead to serious injury or death.

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A prescription brand of hypoallergenic dry powder formula, Neocate manufactured by Nutricia, is being recalled because of a blending error that has resulted in the product having lower levels of protein than declared on the label, according to the Food and Drug Administration (FDA).

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