April 22, 2020

Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers

ISSUE:  The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. 

April 1, 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.

 

Recalled Product

Centers for Medicare & Medicaid Services (CMS) released two comprehensive toolkits on telehealth that are specific to general practitioners as well as providers treating patients with End-Stage Renal Disease (ESRD).

Today, the Centers for Disease Control and Prevention (CDC) released new information on two critical areas of care related to Coronavirus Disease-2019 (COVID-19).

CMS COVID-19 Resources

    Product Description:

    Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

    Reason for Recall:

    The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks.

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