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HSAG ESRD Alerts, Recalls, and Notices

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  • All Ranitidine Products (Zantac): Press Release - FDA Requests Removal

    Wednesday, April 1, 2020
    The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

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  • CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

    Wednesday, April 1, 2020
    CME America is recalling the BodyGuard Infusion Pump Systems because the pumps may have a slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion). The reason for the infusion errors is not known.

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  • Severe Illness Associated with Using Non-Pharmaceutical Chloroquine Phosphate to Prevent and Treat Coronavirus Disease 2019

    Monday, March 30, 2020

    Chloroquine phosphate, when used without a prescription and supervision of a healthcare provider, can cause serious health consequences, including death. Clinicians and public health officials should discourage the public from misusing non-pharmaceutical chloroquine phosphate (a chemical used in home aquariums). Clinicians should advise patients and the public that chloroquine, and the related compound hydroxychloroquine, should be used only under the supervision of a healthcare provider as prescribed medications.

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  • Fecal Microbiota for Transplantation: Safety Alert - Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19

    Wednesday, March 25, 2020
    FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT) and that FDA has determined that additional safety protections are needed.

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  • FDA Alerts Patients and Health Care Professionals of EpiPen Auto-Injector Errors Related to Device Malfunctions and User Administration

    Wednesday, March 25, 2020

    FDA is alerting patients, caregivers and health care professionals that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to:

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  • Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

    Wednesday, March 25, 2020
    While many Americans are sheltering at home to help “flatten the curve” and slow the spread of coronavirus disease (also called COVID-19), they might be tempted to buy or use questionable products that claim to help diagnose, treat, cure, and even prevent COVID-19.

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  • CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion

    Thursday, March 19, 2020

    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.

    CME America has identified that specific Microset Infusion Sets, Catalog Number A120-003XYVA, which have an extended section of tubing longer than standard lengths, prohibitively restrict medication flow to the pumping chamber of the infusion pump.

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  • Class II recall of ten lots of the Revaclear Capillary Dialyzer 300

    Wednesday, March 11, 2020

    The FDA has announced the Class II recall of ten lots of the Revaclear Capillary Dialyzer 300, product code 114745L, UDI 07332414123055, because of possible particulate matter inclusions.  Lot Numbers are C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, and C419126401.

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  • CDC COVID-19 Fact Sheets

    Wednesday, March 11, 2020
    Print resources from the CDC about COVID-19.

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  • ASN - COVID-19 Awareness Poster

    Wednesday, March 11, 2020
    To assist with the sharing of information within the dialysis facility, ASN has created the attached COVID-19 awareness poster for facility use.

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