Tag: FDA

FDA: Class I recall of GE Healthcare’s CARESCAPE R860 Ventilator

Editor's Note The Food and Drug Administration (FDA) on June 28 identified the recall by GE Healthcare of its CARESCAPE R860 Ventilator as Class I, the most serious. The recall was initiated because the ventilator backup batteries, including replacement backup batteries, may run out before they are expected to do…

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By: Judy Mathias
June 29, 2022
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FDA: Class I recall of Baxter’s Volara system with in-line ventilator adaptor

Editor's Note The Food and Drug Administration (FDA) on June 23 identified the recall by Baxter Healthcare Corporation of its Volara system with in-line ventilator adaptor as Class I, the most serious. The Volara system is used to clear mucus out of airways, expand lungs, and treat or prevent pulmonary…

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By: Judy Mathias
June 28, 2022
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FDA: Class I recall of Medtronic’s HVAD batteries

Editor's Note The Food and Drug Administration (FDA), on June 23, identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) batteries as Class I, the most serious. The recall for a single lot (Model Number:1650DE) of HVAD batteries was initiated because of welding defects that allow separation…

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By: Judy Mathias
June 27, 2022
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FDA monitoring pulse oximeter accuracy and limitations

Editor's Note The US Food and Drug Administration (FDA) released a safety communication update on June 21 alerting providers that the agency “continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance.” A May 2022 study published by JAMA Internal Medicine showed that…

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By: Tarsilla Moura
June 23, 2022
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FDA: Class I recall of one lot of Draeger SafeStar 55 Breathing System Filters

Editor's Note The Food and Drug Administration (FDA) on June 21 identified the recall by Draeger, Inc, of one lot (LT2103) of its SafeStar 55 Breathing System Filters as Class I, the most serious. The Breathing System Filter is used as part of a ventilator when a patient is under…

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By: Judy Mathias
June 22, 2022
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FDA, CDC recommend COVID-19 vaccines for children under 5 years old

Editor's Note The Food and Drug Administration (FDA) authorized COVID-19 vaccines for children as young as 6 months old, which expands eligibility to some 20 million babies, toddlers, and preschoolers, CBS News June 17 reports. After convening on Saturday, June 18, the Centers for Disease Control and Prevention (CDC) also…

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By: Tarsilla Moura
June 17, 2022
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FDA: Class I recall of Woodside Acquisitions’ Oral Rapid and Joysbio SARS-CoV-2 Antigen Rapid Test Kits

Editor's Note The Food and Drug Administration (FDA) on June 9 updated the Class I recall by Woodside Acquisitions Inc of its Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) that are not authorized, cleared, or approved by the FDA. The FDA…

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By: Judy Mathias
June 15, 2022
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FDA: Class I recall of Medtronic HVAD Pump Implant Kit

Editor's Note The Food and Drug Administration (FDA) on June 8 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit as Class I, the most serious. The HVAD System is used as a bridge to cardiac transplants. The Kit was recalled because of a…

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By: Judy Mathias
June 9, 2022
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FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators

Editor's Note The Food and Drug Administration on June 3 identified the recall by Philips Respironics of all V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because an internal power fluctuation may cause the ventilator to shut down unintentionally with or without any…

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By: Judy Mathias
June 8, 2022
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FDA: Class I recall of Atrium Medical’s iCast Covered Stent

Editor's Note The Food and Drug Administration (FDA) on June 2 identified the recall by Atrium Medical Corporation of its iCast Covered Stent System as Class I, the most serious. The recall was initiated because of increased complaints about the separation of the balloon or catheter hub from the delivery…

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By: Judy Mathias
June 7, 2022
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