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2017

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  • St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)

    Friday, October 20, 2017
    St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. ICDs and CRT-Ds are both implanted under the...

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  • Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall

    Saturday, October 7, 2017
    Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to...

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  • Hurricanes Irma and Maria in the Caribbean Alert - Level 2, Practice Enhanced Precautions

    Tuesday, September 26, 2017
    Beginning on September 6, 2017, Hurricane Irma crossed the Caribbean, followed on September 16 by Hurricane Maria. The extent of destruction across these countries and territories varies, with many areas flooded and inaccessible. Significant damage from the hurricane has caused problems with water...

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  • Class 2 Device Recall Baxter Amia Automated Peritoneal Dialysis Set with Cassette

    Friday, September 22, 2017
    The firm (Baxter) initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at...

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  • Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury

    Friday, September 22, 2017
    FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a...

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  • Guidance to All Providers Regarding Provision of Services During Hurricane Irma: This Guidance Applies for Both Fee-For-Service and Managed Care Providers

    Monday, September 18, 2017
    It is imperative Florida Medicaid recipients maintain access to services during the disaster period. To this end, the Agency will ensure reimbursement for services that are provided in good faith to eligible recipients...

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  • Rifampin/Penicillin-Resistant Strain of RB51 Brucella Contracted from Consumption of Raw Milk

    Wednesday, September 13, 2017
    The Texas Department of State Health Services, with assistance from CDC, is investigating Brucella RB51 exposures and illnesses that may be connected to the purchase and consumption of raw (unpasteurized) milk from K-Bar Dairy in Paradise, Texas. Symptoms of brucellosis can include: fever, sweats,...

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  • Medtronic Announces Voluntary Recall of Diabetes Infusion Sets

    Tuesday, September 12, 2017
    Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include...

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  • Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance

    Thursday, September 7, 2017
    Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be...

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  • Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing

    Wednesday, September 6, 2017
    FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and...

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