DeRoyal—Procedure Packs Containing Smiths NORMOFLO Irrigation Warming Sets: Warming Sets May Leach Aluminum Ions into Warming Fluids​ [FDA Class I]

October 6, 2021 | Strategic Insights for Health System


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Problem:FDA's Center for Devices and Radiological Health (CDRH) states that the above kits may contain NORMOFLO irrigation warming sets, which were recalled by Smiths because they may leach aluminum ions into warming fluids. FDA's CDRH also states that the manufacturer initiated...

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