FDA-Device2025-02-19Class I

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.

Getinge Usa Sales Inc
Hazard

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.

Sold states
Domestic distribution to Kentucky and Connecticut.
Affected count
6 units
Manufactured in
1 Geoffrey Way, Wayne, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1074-2025

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