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Alerts and Recalls

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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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  • Information for Screening and Management of COVID-19 in the Outpatient Dialysis Facility

    Wednesday, March 11, 2020

    ASN continues to receive questions about the management of patients with confirmed or suspected COVID-19. The Centers for Disease Control and Prevention has posted guidance for healthcare settings, Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings . These FAQs were drafted for dialysis facilities based on current CDC guidance.

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  • Interim Additional Guidance for Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Outpatient Hemodialysis Facilities

    Wednesday, March 11, 2020

    These recommendations should be used with the CDC’s Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings. This information is provided to clarify COVID-19 infection prevention and control (IPC) recommendations that are specific to outpatient hemodialysis facilities. This information complements, but does not replace, the general IPC recommendations for COVID-19.

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  • Updated Guidance on Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)

    Monday, March 9, 2020

    This CDC Health Alert Network (HAN) Update highlights guidance and recommendations for evaluating and identifying patients who should be tested for COVID-19 that were shared on March 4, 2020, on the CDC COVID-19 website at www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.htmlIt supersedes the guidance and recommendations provided in CDC’s HAN 428 distributed on February 28, 2020.

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  • Update and Interim Guidance on Outbreak of Coronavirus Disease 2019 (COVID-19)

    Monday, March 2, 2020

    CDC has published a new February 28, 2020 Health Alert Network Advisory on Update and Interim Guidance on Outbreak of Coronavirus Disease 2019 (COVID-19), replacing the Guidance in the previous February 1, 2020 HAN.

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  • FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

    Thursday, February 20, 2020

    The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies. The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

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  • Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

    Thursday, February 13, 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.

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