Tag: Product Recalls

FDA: Class I recall of Baxter Hillrom WatchCare IMS for RF interference risk

Editor's Note The Food and Drug Administration, on November 23, identified the recall by Baxter Hillrom of its WatchCare Incontinence Management System (IMS) as Class I, the most serious. The recall was initiated because of the risk for radiofrequency (RF) emissions from WatchCare devices that may interfere with other devices,…

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By: Judy Mathias
November 29, 2022
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FDA: Class I recall of Teleflex Iso-Gard Filter S

Editor's Note The Food and Drug Administration (FDA) on November 1 identified the recall of Teleflex’s Iso-Gard Filter S as Class I, the most serious. Iso-Gard filters are breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in operating rooms and ICUs. The recall was initiated…

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By: Judy Mathias
November 3, 2022
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FDA: Class I recall of Jiangsu Well Biotech COVID-19 Ag Rapid Test

Editor's Note The Food and Drug Administration (FDA) on October 12 identified the recall of Jiangsu Well Biotech’s COVID-19 Ag Rapid Test Devices as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance, or approval from the FDA. No…

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By: Judy Mathias
October 26, 2022
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FDA: Philips Respironics recalls certain BiPAP, CPAP masks

Editor's Note The Food and Drug Administration (FDA) on October 19 identified the recall by Philips Respironics of certain masks for BiPAP and CPAP machines as Class I, the most serious. The recall was initiated because magnetic headgear clips that hold the masks in place can cause injury or death…

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By: Judy Mathias
October 24, 2022
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FDA: Class I recall of LivaNova’s LifeSPARC System

Editor's Note The Food and Drug Administration (FDA) on September 30 identified the recall by LivaNova (TandemLife) of its LifeSPARC System, Model LS-1000, as Class I, the most serious. The recall was initiated because of the risk of unintentional extended pump stop during Controller Critical Failure mode, caused by a…

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By: Judy Mathias
October 3, 2022
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FDA: Class I recall of certain Philips Respironics BiPAP machines

Editor's Note The Food and Drug Administration (FDA) on September 23 identified the recall by Philips Respironics of certain models of its BiPAP machines as Class I, the most serious. The recall was initiated because certain machines may contain a plastic contaminated with a noncompatible material. If the plastic is…

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By: Judy Mathias
September 26, 2022
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FDA: Class I recall of Baxter Clearlink Basic Solution Set with Duovent

Editor's Note The Food and Drug Administration (FDA) on September 15 identified Baxter Healthcare Corporation’s recall of its ClearLink Basic Solution Set with Duovent as Class I, the most serious. The recall was initiated because of the risk for leaks that may expose providers and patients to hazardous toxic substances…

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By: Judy Mathias
September 19, 2022
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FDA: Class I recall of Medtronic Xomed NIM Contact, NIM Standard Reinforced EMG Endotracheal Tubes

Editor's Note The Food and Drug Administration on September 12 identified the recall by Medtronic Xomed of its NIM Contact Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube as Class I, the most serious. The recall was initiated after Medtronic Xomed received customer complaints about obstruction of…

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By: Judy Mathias
September 14, 2022
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FDA: Class I recall of Integra’s CereLink ICP Monitor

Editor's Note The Food and Drug Administration (FDA) on August 31 identified the recall by Integra of its CereLink ICP Monitor as Class I, the most serious. The recall was initiated because the device may display incorrect values for a patient’s intracranial pressure (ICP) and display out-of-range pressure readings. If…

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By: Judy Mathias
September 2, 2022
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FDA: Class I recall of Hamilton-C6 Intensive Care Ventilator

Editor's Note The Food and Drug Administration (FDA) on August 29 identified the recall by Hamilton Medical AG of its Hamilton-C6 Intensive Care Ventilator as Class I, the most serious. The recall was initiated because of potential water ingress between the indicator board and the ventilator’s main board that may…

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By: Judy Mathias
September 1, 2022
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