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  • Lifepak 1000 Defibrillators by Physio-Control: Remove and Reinstall Battery

    Monday, January 16, 2017

    Physio-Control announced that the company is launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.   

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  • FDA Medical Device Recall: Nurse Assist Normal Saline Flush IV Syringes

    Wednesday, January 4, 2017

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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  • FDA MedWatch: Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer

    Monday, December 19, 2016

    As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the additional studies reviewed.

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  • ZIKA UPDATE: CDC Guidance for Travel and Testing of Pregnant Women and Women of Reproductive Age

    Wednesday, December 14, 2016

    On November 28, 2016, the Texas Department of State Health Services (TDSHS) reported the first case of locally acquired mosquito-borne Zika virus infection in the city of Brownsville, Cameron County, Texas. On December 9, 2016, four additional cases in people living in proximity to the first case were reported. TDSHS continues to investigate Zika virus transmission in Brownsville.

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  • Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue

    Tuesday, October 18, 2016

    The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest.

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  • Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

    Tuesday, October 4, 2016

    The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active
    infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4–8 weeks.

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  • First Human Case of West Nile Viral Disease in NYC in 2016

    Monday, September 12, 2016

    West Nile viral activity continues to increase in New York City in mosquitoes. The first human case of West Nile viral disease was identified in a Brooklyn man. West Nile virus positive mosquito pools have been identified in all five boroughs.

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  • FDA MedWatch: Recall of six batches of GlucaGen® HypoKit®

    Friday, September 9, 2016

    Novo Nordisk Inc. is recalling six batches of the GlucaGen® HypoKit® in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI).

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  • New CMS Emergency Preparedness Rules

    Thursday, September 8, 2016

    The Centers for Medicare & Medicaid Services (CMS) finalized rules to establish consistent emergency preparedness requirements for healthcare providers participating in Medicare and Medicaid, increase patient safety during emergencies, and establish a more coordinated response to natural and man-made disasters. These new rules will require certain participating providers and suppliers to plan for disasters and coordinate with federal, state, tribal, regional, and local emergency preparedness systems to ensure that facilities are adequately prepared to meet the needs of their patients during disasters and emergency situations. The effective date will be November 16, 2016 and the implementation date will be November 16, 2017.

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  • FDA MedWatch: VASCU-GUARD Peripheral Vascular Patch by Baxter

    Thursday, September 1, 2016

    The FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu- Guard patch) during carotid endarterectomy (CEA). These reports from 2016 include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths potentially related to this issue that occurred shortly after CEA surgery. The device manufacturer, Baxter International, Inc., alerted the FDA to these adverse events.

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