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FDA MedWatch Safety Alerts



Last Build Date: Thu, 16 Feb 2017 09:30:00 -0500

 



Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate

Thu, 16 Feb 2017 09:30:00 -0500

Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.



HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance

Wed, 15 Feb 2017 08:30:00 -0500

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.



Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error

Thu, 09 Feb 2017 11:00:00 -0500

Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death.



Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter

Thu, 09 Feb 2017 09:35:00 -0500

Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.



Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids

Thu, 09 Feb 2017 07:45:00 -0500

Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.



Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions

Thu, 02 Feb 2017 13:24:00 -0500

Reactions can occur within minutes of exposure, and may include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, a life-threatening condition.



Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage

Mon, 30 Jan 2017 14:10:00 -0500

The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.



Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna

Fri, 27 Jan 2017 13:55:00 -0500

Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017



NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall - Potential Inaccurate Test Results

Fri, 27 Jan 2017 13:15:00 -0500

Risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment.



Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial

Wed, 25 Jan 2017 08:00:00 -0500

Injected particulate may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.



ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions

Tue, 17 Jan 2017 10:00:00 -0500

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

Sat, 14 Jan 2017 00:00:00 -0500

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

Fri, 13 Jan 2017 11:00:00 -0500

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

Thu, 12 Jan 2017 09:00:00 -0500

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: Corrective Action - Particulates Generated in Vial

Wed, 11 Jan 2017 17:30:00 -0500

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

Wed, 11 Jan 2017 10:50:00 -0500

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

Mon, 09 Jan 2017 00:00:00 -0500

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

Fri, 23 Dec 2016 09:35:00 -0500

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

Tue, 20 Dec 2016 10:00:00 -0500

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

Fri, 16 Dec 2016 12:01:00 -0500

FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.