August 26, 2019

FDA: Class I recall of Vyaire Medical enFlow fluid warming disposable cartridge

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on August 21 identified Medline Industries’ recall of Centurion Medical Products’ Primary Warmer Pack containing the Vyaire Medical enFlow fluid warming system disposable cartridge as Class I, the most serious.

The recall was initiated because the cartridge may elute aluminum into infused fluids during use, potentially exposing patients to unsafe aluminum levels.

Medline Industries received four customer complaints. No serious injuries or deaths were reported.

The affected products were only distributed to St Luke’s Health System in Idaho from October 9, 2018, to March 28, 2019.

 

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