FDA Sounds Alarm: Cluster Of Class I Recalls Prompts Aluminum Toxicity Warning From Agency
The US agency has warned health care providers that certain devices used to warm fluids for bodily circulation could leach dangerous levels of aluminum.
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Thousands of procedure packs made by DeRoyal Industries Inc. are being recalled because they include a NORMOFLO Irrigation Warming Set that was the subject of a recent high-risk class I recall by manufacturer Smiths Medical because the device may leach aluminum.
King & Spalding quality expert Eric Henry urges device makers to be inspection-ready by making sure the right people are in the right roles.
The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.