FDA: Class I recall of Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs
Editor's Note The Food and Drug Administration (FDA), on October 29, identified the recall by Datascope/Getinge/Maquet of its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs as Class I, the most serious. The recall was initiated because of the risk of the battery failing and having a shortened run time, which…
FDA: Class I recall of DeRoyal procedure packs containing Smiths Medical Normoflo irrigation warming sets
Editor's Note The Food and Drug Administration (FDA), on October 6, identified the recall by Deroyal Industries of its procedure packs containing Smiths Medical Normoflo irrigation warming sets as Class I, the most serious. The recall was initiated because of the possibility of harmful levels of aluminum leaching into the…
FDA: Class I recall of Imperative Care ZOOM 71 Reperfusion Catheter
Editor's Note The Food and Drug Administration (FDA) on October 6 identified the recall by Imperative Care Inc of its ZOOM 71 Reperfusion Catheter as Class I, the most serious. The ZOOM 71 Reperfusion Catheter is used to remove blood clots from a patient’s brain within 8 hours of an…
FDA: Class I recall of Amsorb Plus used to absorb carbon dioxide in anesthesia machines
Editor's Note The Food and Drug Administration (FDA), on September 23, identified the recall by Armstrong Medical of certain lots of its Amsorb Plus Prefilled G-Can 1.0L canisters as Class I, the most serious. Amsorb Plus is a chemical substance used in anesthesia machines to absorb carbon dioxide the patient…
FDA: Class I recall of Medtronic Pipeline Flex Embolization devices
Editor's Note The Food and Drug Administration (FDA), on September 20, identified Medtronic’s recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology as Class I, the most serious. The devices, which are used to treat brain aneurysms, were recalled because there is a risk…
FDA: Class I recall of Normoflo irrigation fluid warmers, warming sets
Editor's Note The Food and Drug Administration (FDA) on September 15 identified the recall of Smiths Medical Normoflo irrigation fluid warmers and warming sets as Class I, the most serious. The recall was initiated because of the potential for aluminum ions leaching into warmed fluids, potentially exposing patients to high…
FDA: Cardinal Health recalls Monoject Saline Flush Prefilled Syringes
Editors Note The Food and Drug Administration (FDA) on August 23 identified the recall by Cardinal Health of its Monoject Saline Flush Prefilled Syringes as Class I, the most serious. Cardinal Health is recalling three models of the syringes because the syringe plunger may pull air into the syringe after…
ECRI partners with Nuvolo on standardization of device data
Editor's Note ECRI on July 20 announced a collaborative partnership with Nuvolo, an independent software vendor involved in cloud-based connected workplace solutions, based in Paramus, New Jersey. The partnership integrates ECRI’s standardization of medical device data with Nuvolo’s Connected Workplace for Healthcare. This automated process enables standardization of device data…
FDA: Class I recall of Medtronic angiographic guidewire
Editor's Note The Food and Drug Administration (FDA) on July 2 identified the recall by Medtronic Vascular of its angiographic guidewire component as Class I, the most serious. The recall was initiated because the devices were not sterilized before being shipped to hospitals. The guidewire is used during angiography or other interventional…
FDA: Class I recall of Avid Medical convenience kits
Editor's Note The Food and Drug Administration on June 25 identified the recall by Avid Medical of its convenience kits for medical-surgical procedures as Class I, the most serious. The company is recalling those kits that contain BD/Carefusion’s Chloraprep 3 mL applicator because of the risk of contamination of the…
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