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…
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…
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…
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…
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…
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…
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…
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…
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…
Editor's Note The Food and Drug Administration on June 3 identified the recall by Philips Respironics of all V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because an internal power fluctuation may cause the ventilator to shut down unintentionally with or without any…