medical Class I Updated 2019-07-03

Vyaire Medical recalls enFlow Disposable Cartridge with IV Extension Set, used for

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number: 980202EU. All units distributed through March 7, 2019.
View official government recall

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