FDA issues Safety Communication on ED-3490TK duodenoscope by Pentax
Editor's Note The Food and Drug Administration (FDA) on January 17 issued a Safety Communication to inform Pentax ED-3490TK video duodenoscope users of updated recommendations to help prevent the spread of infection associated with the use of these devices. Since a February 19, 2016, Safety Communication to inform users about…
FDA issues Safety Alert on Lifepak 1000 defibrillators
Editor's Note The Food and Drug Administration (FDA) on January 14 issued a Safety Alert announcing the voluntary field action by Physio-Control (Redmond, Washington) notifying its customers to immediately remove and reinstall batteries in the Lifepak 1000 defibrillator. The company has received 34 reports of customers attempting to use the…
FDA: Certain Fujifilm duodenoscopes removed from clinical use
Editor's Note The Food and Drug Administration (FDA) on January 13 issued a Safety Communication that Fujifilm Medical Systems (Wayne, New Jersey) will remove its legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use. Fuji will replace the 250/450 models with the ED-530XT model,…
FDA issues safety alert on implantable cardiac devices, transmitters by St Jude Medical
Editor's Note The Food and Drug Administration on January 9 issued a safety alert for St Jude Medical’s (St Paul, Minnesota) radio frequency-enabled implantable cardiac devices and Merlin@home transmitters on reducing the risk of patient harm from cybersecurity vulnerabilities. The vulnerabilities, if exploited, could allow an unauthorized user to remotely…
FDA classifies recall of IV Flush Syringes by Nurse Assist as Class I
Editor's Note The Food and Drug Administration (FDA) on January 4, 2017, classified the recall by Nurse Assist (Haltom City, Texas) of its IV Flush Syringes as Class I, the most serious. The recall was initiated because of a potential link to Burkholderia cepacia blood stream infections with the syringes.…
FDA issues safety warning for battery-powered mobile medical carts
Editor's Note The Food and Drug Administration (FDA) on December 27 issued a warning to healthcare facilities of potential safety risks associated with battery-powered mobile medical carts. The FDA has received reports of explosions, fires, smoking, and overheating of the lithium and lead acid batteries in these carts that required…
FDA: Class I recall of Standard Offset Cup Impactor by Greatbatch Medical
Editor's Note The Food and Drug Administration (FDA) on December 20 classified the recall by Greatbatch Medical (Frisco, Texas) of its Standard Offset Cup Impactor with a POM-C handle as Class I, the most serious. The recall was issued because the Impactor failed sterility testing when sterilized in a dedicated…
FDA bans powdered gloves
Editor's Note The Food and Drug Administration (FDA) on December 19, 2016, published a final rule banning powdered surgeon gloves, powdered patient examination gloves, and absorbable powder for surgeon’s gloves, effective January 18, 2017. The FDA says it issued the ban because these products present unreasonable and substantial risks to…
FDA: New warning on general anesthesia and sedation in children, pregnant women
Editor's Note The Food and Drug Administration (FDA) on December 14 issued a new warning saying that repeated or lengthy use of general anesthetics and sedation drugs during surgical procedures in children younger than 3 years or pregnant women during the third trimester may affect the development of children’s brains.…
FDA: Class I recall of Centurion Convenience Kits with Multi-Med Single Lumen Catheters
Editor's Note The Food and Drug Administration (FDA) on December 9 categorized the recall by Centurion Medical Products (Williamston, Michigan) of its Centurion Convenience Kits containing Multi-Med Single Lumen Catheters as Class I, the most serious. There may be excess material at the tip of the catheters from the manufacturing…
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