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January 17, 2017 at 10:00 AM
Updated recommendations to help prevent the spread of infection associated with the use of these devices.
January 14, 2017 at 12:00 AM
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
January 13, 2017 at 11:00 AM
Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
January 12, 2017 at 9:00 AM
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
January 11, 2017 at 5:30 PM
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
January 11, 2017 at 10:50 AM
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
January 09, 2017 at 12:00 AM
These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.
December 23, 2016 at 9:35 AM
IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. Do not rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions.
December 20, 2016 at 10:00 AM
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
December 16, 2016 at 12:01 PM
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
December 14, 2016 at 12:01 PM
Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain.
December 12, 2016 at 3:05 PM
FDA approved label updates to describe additional studies reviewed.
December 09, 2016 at 3:30 PM
Excess material may separate from catheter during use and enter patient’s bloodstream, resulting in serious adverse health consequences such as blood clots, embolism of the excess material to vital organs, or death.
December 01, 2016 at 8:40 AM
Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
December 01, 2016 at 8:15 AM
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
November 26, 2016 at 10:00 AM
DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
November 25, 2016 at 12:00 AM
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
November 22, 2016 at 2:50 PM
Can lead to serious adverse health consequences including embolism, stroke, or death.
November 21, 2016 at 3:00 PM
Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening.
November 21, 2016 at 12:30 PM
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
November 18, 2016 at 2:00 PM
People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
November 15, 2016 at 12:10 PM
Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.
November 08, 2016 at 3:50 PM
Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
November 08, 2016 at 9:15 AM
Acute lead poisoning may cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Long term exposure can lead to permanent damage to the central nervous system. Posted 11/08/2016
October 28, 2016 at 2:45 PM
Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.