Getinge Usa Sales Inc recalls Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Fl…

Recall date

January 15, 2025

Source

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

Recall number

Z-1074-2025

FDA classification

Class I

Brand / firm

Getinge Usa Sales Inc

Sold / distributed

Domestic distribution to Kentucky and Connecticut.

Why it was recalled

Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.

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

Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.