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HSAG ESRD Alerts, Recalls, and Notices

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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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  • 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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  • FDA MedWatch: Pioglitazone-containing Medicines, Increased Risk of Bladder Cancer

    Monday, December 12, 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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  • FDA MedWatch: Convenience Kits Containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate

    Friday, December 9, 2016

    Centurion is recalling the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.

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  • CMS publishes proposed rule on Fire Safety Requirements for Applicable Dialysis Facilities

    Thursday, November 3, 2016

    Today, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule to update Medicare fire protection guidelines for certain dialysis facilities to ensure that patients are protected from fire while receiving treatment in those facilities. CMS strives to promote health and safety for all patients, family, and staff in every provider and supplier setting, and fire safety requirements are an important part of this effort.

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

    Monday, October 17, 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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  • FDA MedWatch: Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected

    Tuesday, October 11, 2016

    FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices. See the FDA Safety Communication for a listing of affected devices and data summary.

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

    Tuesday, October 4, 2016

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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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  • Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas

    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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