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Vyaire Medical recalls enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Recalled July 3, 2019 · FDA recall Z-1385-2019 · Vyaire Medical
Hazard
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. · FDA Class I
Units
5,782,820 units total
Sold at
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.
Description
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Product
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Manufacturer(s)
Vyaire Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →