FDA Enforcement
Class I
Ongoing
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.
Recall: Z-1074-2025
·
Reported February 19, 2025
Enforcement
- Recall Number
- Z-1074-2025
- Event ID
- 96083
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Getinge Usa Sales Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 19, 2025
- Initiation Date
- January 15, 2025
- Classification Date
- February 7, 2025
- Address
- 1 Geoffrey Way, Wayne, NJ, 07470-2035, United States
Description
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.
Reason
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.
Code Info
Model Number: 6682285. UDI-DI: 07325710001141. Serial Numbers: 3761, 7635, 7633, 7630, 7632, 7631.
Distribution
Domestic distribution to Kentucky and Connecticut.
Quantity
6 units