Tag: Product Recalls

FDA adds AEDs, chest drains to device shortage list

Editor's Note The Food and Drug Administration (FDA) on July 19 added automated external defibrillators (AEDs) and chest drains/suction canisters and autotransfusion systems to its list of medical device shortages during COVID-19. The shortage of chest drains/suction canisters and autotransfusion systems is because of increased demand. The shortage of AEDs…

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By: Judy Mathias
July 26, 2022
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FDA: Class I recall of certain Smiths Medical Medfusion Syringe Infusion Pumps

Editor's Note The Food and Drug Administration on July 20 identified the recall by Smiths Medical of certain Medfusion 3500 and 4000 Syringe Infusion Pumps as Class I, the most serious. The recall was initiated because of eight software malfunctions that affect different serial numbers and software versions. There have…

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By: Judy Mathias
July 21, 2022
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FDA: Class I recall of American Contract Systems' COVID Test Kit Nonsterile, Clean Catch Urine Kit

Editor's Note The Food and Drug Administration (FDA) on July 14 identified the recall of American Contract Systems’ COVID Test Kit Nonsterile and Clean Catch Urine Kit as Class I, the most serious. The recall was initiated because the Kits were assembled in an uncontrolled facility by people without proper…

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By: Judy Mathias
July 18, 2022
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FDA: Class I recall of Getinge Flow-c, Flow-e Anesthesia Systems

Editor's Note The Food and Drug Administration (FDA) on July 6 identified the recall by Getinge USA Sales Inc of its Flow-c and Flow-e Anesthesia Systems as Class I, the most serious. The recall was initiated after reports of cracked or broken on/off switchs on the systems’ suction units. If…

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By: Judy Mathias
July 12, 2022
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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: 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: 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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