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).
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.
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.
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.
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.
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.
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.
Edwards Lifesciences Corp. is recalling a hemodialysis system because the system can create a fluid imbalance in patients that may lead to serious injury or death, according to an announcement by the Food and Drug Administration (FDA).
Videx and Videx EC (Ididanosine), a medicine used to treat human immunodeficiency virus (HIV) infection, has been associated with a rare but serious complication in the liver known as non-cirrhotic portal hypertension, according to the Food and Drug Association (FDA) Drug Safety Communication. The FDA issued the warning to health care professionals and patients after receiving reports of non-cirrhotic portal hypertension through its FDA Adverse Event Reporting System, and has revised the didanosine drug label to include information about this risk.
The Food and Drug Administration (FDA) is warning neuropsychiatric health care professionals to carefully consider the long-term effects of Zyprexa (olanzapine) when prescribing the medication to adolescents for the treatment of schizophrenia and bipolar I disorder, and in many cases the health care professional may consider prescribing other drugs to adolescents first. Zyprexa may increase the potential for weight gain and hyperlipidemia, or high blood cholesterol and triglycerides in the blood. High cholesterol increases ones risk for cardiovascular disease and may predispose one to acute pancreatitis.