FDA-Device2019-07-03Class I
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Vyaire Medical
Hazard
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Sold states
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, United Republic of Tanzania, South Africa, Panama, and Viet Nam.
Affected count
5,782,820 units total
Manufactured in
26125 N Riverwoods Blvd, N/A, Mettawa, IL, United States
Products
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2019Don't want to check this manually?
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