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…
Royal Philips issues urgent safety alert for fluoroscopy system
Editor's Note Royal Philips has issued an urgent field safety notice for its CombiDiagnost R90 GCF fluoroscopy system, the January 10 MassDevice reports. When the tilting feature is used, the device could be locked in a “Table Up/Down” state, an issue that could result in the entry of contrast agent…
FDA: Class I recall of Medfusion 4000 Syringe Pumps
Editor's Note The Food & Drug Administration (FDA) on December 19, 2019, identified the recall by Smiths Medical ASD, Inc of its Medfusion 4000 Syringe Pumps as Class I, the most serious. The recall was initiated because of malfunctioning low-battery alarms, which may lead to an interruption of therapy. The…
FDA: Class I recall of LivaNova VNS Therapy SenTiva Generator
Editor's Note The Food & Drug Administration (FDA) on January 2 identified the recall by LivaNova of its VNS Therapy SenTiva Generator System as Class I, the most serious. The recall was initiated because of an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy…
FDA: Class I recall of Cook Medical’s CrossCath Support Catheters
Editor's Note The Food and Drug Administration (FDA) on December 17 identified the recall by Cook Medical of its CrossCath Support Catheters as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause the radiopaque marker bands on the catheters to dislodge or…
FDA: Medtronic recalls SynchroMed II implantable drug infusion pump
Editor's Note The Food and Drug Administration (FDA) on December 16 announced that Medtronic has recalled its SynchroMed II implantable infusion pump. The pump is being recalled because of the potential presence of foreign particles inside the pump motor assembly that may lead to a pump motor stall. Medtronic has…
FDA: B. Braun recalls blood administration sets
Editor's Note The Food & Drug Administration (FDA) on November 26 announced a voluntary recall by B. Braun Medical (Bethlehem, Pennsylvania) of 22 lots of blood administration sets. The recall was initiated because of the potential for leakage at the joint between the blood filters and tubing. This could force…
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