Editor's Note The Food and Drug Administration (FDA) on August 16 classified the recall by Cook Medical Inc (Bloomington, Indiana) of its Zenith Alpha Thoracic Endovascular Graft as Class I, the most serious. Cook Medical is aware of reported cases where the graft became blocked or closed with blood clots…

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Editor's Note The Food and Drug Administration (FDA) on August 10 issued a Safety Alert to update healthcare providers on five reports of unanticipated deaths that have occurred from 2016 to the present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric…

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Editor's Note The Food and Drug Administration (FDA) on August 4 classified the recall by Datascope Corp/Maquet (Mahwah, New Jersey) of its intra-aortic balloon pump as Class I, the most serious. The recall was issued because of the risk of a valve failure, which prevents the balloon from inflating and…

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Editor's Note The Food and Drug Administration on July 28 issued a Safety Alert for compounded triamicinolone and moxifloxacin for intravitreal injection by Guardian Pharmacy Services (Dallas, Texas). [The Guardian Pharmacy Services in Dallas is not affiliated with the national long-term care Guardian Pharmacy Services, LLC headquartered in Atlanta.] The…

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Editor's note The Food and Drug Administration (FDA) on July 31 announced the recall by ICU Medical, Inc (San Clemente, California) of one lot of 0.9% sodium chloride injection, USP 1,000 mL. The recall was issued because of a confirmed customer complaint of particulate matter identified as stainless steel in…

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Editor's Note The Food and Drug Administration (FDA) on July 6 announced the recall by Oscor Inc (Palm Harbor, Florida) of its Atar extension cables. The recall was initiated because, during use, some of the cables were separating from the connectors at the proximal end. The Atar cable is an…

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Editor's Note The Food and Drug Administration (FDA) on June 30 issued a draft guideline: “Product Identifier Requirements Under the Drug Supply Chain Security Act−Compliance Policy.” The draft guidance describes the FDA’s enforcement of requirements related to unique device identification (UDI), specifically those that manufacturers affix or imprint on a…

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Editor's Note The Food and Drug Administration on June 27 announced the recall by PharMEDium Services of specific lots of potassium phosphate and succinylcholine chloride because of a lack of sterility assurance. The products being recalled were compounded using certain Hospira products, which were recalled on June 15 because microbial…

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Editor's Note The Food and Drug Administration (FDA) has announced the creation of a new centralized Digital Health Unit in its Center for Devices and Radiological Health, which together with draft guidance on software as a medical device, is designed to support technological innovation and advance digital health, the June…

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Editor's Note The Food and Drug Administration (FDA) on June 23 posted the recall by Fagron Sterile Services (Wichita, Kansas) of three lots of succinylcholine chloride 20 mg/mL 5 mL syringes because of microbial growth detected during a simulation of the manufacturing process. This is a secondary recall of products…

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