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…
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…
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…
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…
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…
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…
FDA: Class I recall of Intera 3000 Hepatic Artery Infusion Pump
Editor's Note The Food and Drug Administration on August 29 identified the recall by Intera Oncology of its Intera 3000 Hepatic Artery Infusion Pump as Class I, the most serious. The company is recalling the pumps after receiving reports from clinicians that the pumps were delivering medication faster than expected.…
FDA: Class I recall of Medtronic’s HeartWare HVAD system batteries
Editor's Note The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious. Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail. A similar recall…
FDA: Hospira recalls another lot of Propofol
Editor's Note The Food and Drug Administration (FDA) on August 22 posted the Hospira Inc (a Pfizer company) recall of one lot of Propofol Injectable Emulsion (containing Benzyl alcohol), 100 mL single patient use glass fliptop vials, lot EA7470. The recall was initiated because of visible particulates observed in two…
FDA: Class I recall of BD Intraosseous Infusion System
Editor's Note The Food and Drug Administration (FDA) on August 11 classified the recall by Becton Dickinson (BD) of its Intraosseous Infusion System, which includes Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers, as Class I, the most serious. The recall was initiated for three separate…
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