FDA MedWatch Safety Alerts
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions
Updated recommendations to help prevent the spread of infection associated with the use of these devices.
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use
Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall - Particulates Generated in Vial
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified
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.
ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions
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.
Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women
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.
Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer
FDA approved label updates to describe additional studies reviewed.
Convenience Kits containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate
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.
Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients
Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient
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.
DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk
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.
Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
FindrWIRZ Guidewire System by SentreHeart: Class I Recall - Coating Separation
Can lead to serious adverse health consequences including embolism, stroke, or death.
Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance
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.
Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
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