Tag: Ventilators

FDA: Class I recall of Mallinckrodt One-Way Valve, 22F x 22M

Editor's Note The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious. The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air…

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By: Judy Mathias
September 13, 2023
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FDA: Class I recall of certain Hamilton ventilators

Editor's Note The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious. The recall was initiated because of software issues that may cause the ventilators to stop without notice. There have…

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By: Judy Mathias
August 31, 2023
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FDA: Class I recall of certain Philips Respironics ventilators

Editor's Note The Food and Drug Administration (FDA), on August 14, identified the recall by Philips Respironics of its Trilogy Evo, Evo 02, EV300, and Evo Universal Ventilators as Class I, the most serious. The recall was initiated after detecting dust and dirt from the environment in the air path…

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By: Judy Mathias
August 15, 2023
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FDA: Class I recall of Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilators

Editor's Note The Food and Drug Administration (FDA), on July 13, identified the recall by Draeger Medical of its Oxylog 3000 Plus Emergency and Transport Ventilators as Class I, the most serious. The recall was initiated because of reports that the ventilator may not automatically switch back to using AC…

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By: Judy Mathias
July 14, 2023
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