Vyaire Medical recalls enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.

Recall date

March 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1385-2019

FDA classification

Class I

Brand / firm

Vyaire Medical

Sold / distributed

Worldwide Distribution. US nationwide, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Hungary, Israel, India, Jordan, Korea, Kuwait, Kazakhstan, Lebanon, Macedonia, Mexico, Malaysia , Myanmar, Netherlands, New Zealand, Oman, Peru, Qatar, Russian Federation, Saudi Arabia, Thailand, Turkey, Uni…

Why it was recalled

Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.