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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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  • HURRICANE HARVEY

    Friday, August 25, 2017
    Hurricane Harvey is a life-threatening and rapidly intensifying storm that is expected to make landfall on the Texas Gulf Coast with devastating rainfall flooding, dangerous storm surge flooding, and destructive winds. Below are some helpful resources for hurricane preparation and updates in storm...

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  • Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

    Monday, August 21, 2017
    Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.

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  • Increase in Reported cases of Cyclospora cayetanensis Infection, United States, Summer 2017

    Monday, August 7, 2017
    The Centers for Disease Control and Prevention (CDC), State and Local Health Departments, and the Food and Drug Administration (FDA) are investigating an increase in reported cases of cyclosporiasis. The purpose of this HAN Advisory is to notify public health departments and healthcare facilities...

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  • Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall - May Crack or Break If Exposed To Certain Chemicals

    Friday, July 7, 2017

    Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar.

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  • Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks

    Friday, July 7, 2017

    Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents.

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  • FDA Med Watch: Clindamycin Injection ADD - Vantage Vials by Alvogen - Recall: Lack of Sterility Assurance

    Monday, June 19, 2017

    Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.

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  • CMS Memo: REVISED ESRD Facilities - Filling Saline Syringes at the Patient Treatment Station

    Tuesday, June 6, 2017

    The 2008 ESRD Conditions for Coverage at 42 CFR 494.30(b)(2) state that the facility must "ensure that the clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications…"

    Dialysis procedures for initiation and discontinuation of hemodialysis treatments require the use of sterile normal saline in syringes to aid in the care of a patient’s vascular access. During survey observations, ESRD facilities have been noted to fill syringes with saline for vascular access care or to flush medications by drawing saline from the single dose saline bag or the IV tubing connected to the patient at the dialysis station.

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