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September 2017

Inside Hospital with Busy Nurses Patient with Doctor
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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

    Monday, September 18, 2017
    Guidance to All Providers Regarding Provision of Services During Hurricane Irma. This Guidance Applies for Both Fee-For-Service and Managed Care Providers.

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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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  • Hurricane Harvey—Clinical Guidance for Carbon Monoxide (CO) Poisoning

    Tuesday, September 5, 2017
    Hurricane Harvey made landfall between Port Aransas and Port O’Connor, Texas on August 25, 2017, causing 300,000 persons to lose power. When power outages occur during emergencies such as hurricanes or winter storms, the use of alternative sources of fuel or electricity for heating, cooling, or...

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  • Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection

    Friday, September 1, 2017
    Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a...

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