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Medical Devices / Submissions and Approvals

Vyaire Recalls Fluid Warming System Cartridges

July 2, 2019
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Vyaire has issued a Class I recall for nearly three million disposable cartridges used with its enFlow fluid warmer device.

The system, which is cleared by the FDA for warming blood, blood products and IV solutions before administration and is used to prevent hypothermia, was found to have risks of aluminum exposure. Specifically, when heating up, the device may release aluminum into the fluids and expose patients.

There have been no injuries or deaths reported, the agency said, but it urged healthcare professionals to safely dispose of any impacted cartridges.

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