Recalls

Recalls

BEASLEY ALLEN LEGAL NEWS | March 15, 2010

A Food and Drug Administration (FDA) black box warning has been added to the anti-blood clotting medication Plavix (Clopidogrel Bisulfate), alerting patients and health care professionals that some people who take the drug may not be able to effectively metabolize the medication and thus may not receive the full benefits of Plavix. An estimated 2 to 14 percent of the population are poor metabolizers of Plavix.




Recalls

BEASLEY ALLEN LEGAL NEWS | March 15, 2010

A recall of ready-to-eat meat products due to possible salmonella contamination spurred by an earlier recall of an ingredient used in processed foods, has sparked another recall, this on four McCormick & Co. products. The products contain hydrolyzed vegetable protein (HVP), a flavor enhancer, that was recalled on March 4, 2010 recall by the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS). The recall on the McCormick & Co. foods was initiated because the HVP ingredient was added after salmonella prevention steps were applied.




Recalls

BEASLEY ALLEN LEGAL NEWS | March 12, 2010

Nearly 2 million chicken and beef products from two different distributors are being recalled because the foods may be contaminated with salmonella, according to the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS).




Recalls

BEASLEY ALLEN LEGAL NEWS | March 12, 2010

WASHINGTON, D.C.- The U.S. Consumer Product Safety Commission (CPSC) is advising parents and caregivers to be cautious when using infant slings for babies younger than four months of age. In researching incident reports from the past 20 years, CPSC identified and is investigating at least 14 deaths associated with sling-style infant carriers, including three in 2009. Twelve of the deaths involved babies younger than four months of age.




Recalls

BEASLEY ALLEN LEGAL NEWS | March 8, 2010

A medical device used to pass catheters through the heart is being recalled by the manufacturer because the tip of the device may break off while the sheath is in the blood vessels, which could lead to serious injury or death. The Food and Drug Administration notified health care professionals this week of the Class 1 recall on Thomas Medical Products Inc., Transseptal Sheath Introducer Kits. Class 1 recalls are the most serious type of recall issued by the FDA and involve situations in which there is reasonable probability that use of the products will cause serious adverse health consequences or death.




Recalls

BEASLEY ALLEN LEGAL NEWS | March 8, 2010

Prescription medical devices used to treat pediatric and adult patients with kidney failure are being recalled by the Food and Drug Administration (FDA) because the devices may cause serious breathing and heart problems that can result in serious injury or death. The Class 1 recall involves Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems that have been in distribution since 1994. A Class 1 recall is the most serious type of recall issued by the FDA and involves situations in which there is reasonable probability that use of the products will cause serious adverse health consequences or death.




Recalls

BEASLEY ALLEN LEGAL NEWS | March 1, 2010

LifeScan, Inc., and the Food and Drug Administration (FDA) are notifying health care professionals and consumers of a recall involving eight lots of OneTouch SureStep Test Strips used by people with diabetes to measure their blood glucose levels at home. The test strips may give falsely low glucose results when the glucose level is higher than400 mg/dL.




Recalls

BEASLEY ALLEN LEGAL NEWS | February 16, 2010

The Food and Drug Administration (FDA) is warning health care professionals about a recall of BD Q-Syte Luer Access Devices, a needleless valve, and BD Nexiva Closed IV Catheter Systems, both manufactured by BD. The devices are intended for use with other infusion therapy products to administer fluids into the intravenous system. Use of the devices may cause an air embolism or leakage of blood or therapeutic product, which may cause serious injury or death.




Recalls

BEASLEY ALLEN LEGAL NEWS | February 15, 2010

The Food and Drug Administration (FDA) is warning emergency medical professionals, health care professionals and consumers about a recall of Powerheart, Cardiovive, CardioLife models of Cardiac Science Automated External Defibrillators (AED) because the devices may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. Cardiac Science Corporation says the AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. About 12,200 devices are affected by the recall.




Recalls

BEASLEY ALLEN LEGAL NEWS | February 8, 2010

The Food and Drug Administration (FDA) has issued a Class I recall on sheaths that are inserted in blood vessels because there is a risk the sheath tip could break off in the body and lead to serious, life-threatening complications. Class I recalls are the most severe type of FDA recall and are only issued when the there is a potential for serious injury or death.