FDA: Class I recall of ACIST Kodama Intravascular Ultrasound Catheter
Editor's Note The Food and Drug Administration (FDA), on March 17, identified the recall by ACIST of its Kodama Intravascular Ultrasound Catheter as Class I, the most serious. The recall was initiated because the O-ring housing tubing may squeeze and damage the O-ring. If there is damage, broken O-ring pieces…
FDA: Class I recall of Medtronic's HVAD Pump Implant Kits
Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…
FDA: Class I recall of Alaris Infusion Pump System and Modules
Editor's Note The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System Infusion Pumps and Modules as Class I, the most serious. The recall was initiated because of multiple system errors, software errors, and use-related errors. The errors can…
FDA: Class I recall of King Systems’ video laryngoscope adapter
Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by King Systems of its King Vision Video Laryngoscope Adapter (size ½) as Class I, the most serious. The recall was initiated because all devices from the affected lots show a reversed image on the display,…
FDA: Class I recall of Tytek Medical TM-317 PneumoDart-Pneumothorax Needle
Editor's Note The Food & Drug Administration on February 25 identified the recall of Tytek Medical’s TM-317 PneumoDart-Pneumothorax Needle as Class I, the most serious. The recall was initiated because of the risk of blockage in the needles caused by the presence of adhesive from the assembly process. The company…
FDA: Class I recall of Abbott coronary dilatation catheters
Editor's Note The Food & Drug Administration on February 19 identified the recall by Abbott Vascular of its NC Trek RX and NC Traveler RX Coronary Dilatation Catheters (diameter 4.0 mm, 4.5 mm, and 5.00 mm) as Class I, the most serious. The recall was initiated because of failure of…
FDA: Class I recall of GE Healthcare CARESCAPE Respiratory Modules, Airway Gas Option
Editor's Note The Food and Drug Administration (FDA) on February 4 identified the recall by GE Healthcare of its CARESCAPE Respiratory Modules and Airway Gas Option as Class I, the most serious. The recall was initiated because of a manufacturing issue that may cause the devices to display incorrect oxygen…
Coronavirus could disrupt healthcare supply chain
Editor's Note The US healthcare industry should prepare for a disruption in the supply chain for disposable medical-surgical devices and high-tech therapeutic and diagnostic products from China amid the coronavirus outbreak, the January 31 Modern Healthcare reports. Data show that devices and diagnostic products from China account for about 3%…
Cardinal Health recalls more than 9 million surgical gowns
Editor's Note Cardinal Health is voluntarily recalling 9.1 million potentially contaminated surgical gowns, 7.7 million of which were distributed to 2,807 facilities across the country, the January 22 Becker’s Hospital Review reports. The company took the action after learning of unsanitary environmental conditions at a plant in China that manufacturers…
FDA: Quality issues with Cardinal Health surgical gowns, packs
Editor's Note The Food & Drug Administration (FDA) on January 16 announced that Cardinal Health has alerted it customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain the gowns. Cardinal Health and the FDA recommend that customers immediately discontinue use…
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