FDA: Class I recall of HeartStart MRx Defibrillator
Editor's Note The Food & Drug Administration (FDA) on February 9 classified the recall by Philips Electronics (Andover, Massachusetts) of its HeartStart MRx Defibrillator as Class I, the most serious. The recall was initiated because of micro cracks in the gas discharge tube that allow internal gasses to escape and…
FDA: New imaging technology promises stable supply of imaging isotope
Editor's Note The Food & Drug Administration (FDA) Commissioner, Scott Gottlieb, MD, on February 8 announced the role the FDA played in the groundbreaking effort to develop a new imaging technology−the RadioGenix System. The technology, which resulted from a collaboration across the federal government and industry, has the potential to…
FDA clears updated design, labeling for Pentax duodenoscope
Editor's Note The Food and Drug Administration (FDA) on February 7 announced that it had cleared the updated design and labeling for Pentax Medical's duodenoscope Model ED-3490TK. Pentax replaced the forceps elevator mechanism, O-ring seal, and distal end cap, and updated the Operation Manual to recommend annual maintenance. The design…
FDA: Class I recall of AirLife Humidification Chamber, Heated Breathing Circuit Kits
Editor's Note The Food and Drug Administration (FDA) on January 31 classified the recall by Vyaire Medical (Mettawa, Illinois) of its AirLife Humidification Chamber and Heated Breathing Circuit Kits as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause parts of the…
FDA: AuroMedics recalls one lot of Levofloxacin
Editor's Note The Food & Drug Administration (FDA) on January 18 announced the recall by AuroMedics (East Windsor, New Jersey) of one lot of Levofloxacin in 5% Dextrose Injection 250 mg/50 mL in a single-use flexible container (NDC 55150-243-46, Lot CLF160003, Expiry date May 2018). The product has been found…
FDA: Baxter recalls another lot of injectable amiodarone
Editor's Note The Food & Drug Administration (FDA) on January 23 announced the expansion by Baxter (Deerfield, Illinois) of its recall of Nexterone (amiodarone HCL) 150 mg/100 mL premixed injection to include a second lot (NC 109123). Lot NC 109925 was recalled in November 2017. The recall was initiated…
FDA issues Safety Alert for Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
Editor's Note The Food & Drug Administration (FDA) on January 17 issued a Safety Alert for the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator because of concerns that the device may fail to deliver treatment to patients if the device is not replaced soon after displaying “Call for service: Device has…
FDA updates Safety Alert for Cortrak 2 Enteral Access System
Editor's Note The Food & Drug Administration (FDA) on January 12 updated a Safety Alert about pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems (Buffalo Grove, Illinois). Several of the events were associated with cardiopulmonary arrest, and there were…
FDA delays UDI compliance dates for class I, unclassified devices
Editor's Note The Food and Drug Administration (FDA) on January 12 announced a delay in enforcement of unique device identification (UDI) requirements for class I and unclassified devices until September 24, 2020. The FDA also will not enforce direct mark requirements for these devices until September 24, 2022. The guidance…
FDA: Class I recall of Certitude Delivery System
Editor's Note The Food and Drug Administration (FDA) on January 11 classified the recall by Edwards LifeSciences (Irvine, California) of its Certitude Delivery System as Class I, the most serious. The system is used for delivery of the Edwards SAPIEN 3 transcatheter aortic heart valve. The recall was issued because…
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