Z-1074-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2025
- Initiation Date
- January 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product 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 for Recall
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.
Distribution Pattern
Domestic distribution to Kentucky and Connecticut.
Code Information
Model Number: 6682285. UDI-DI: 07325710001141. Serial Numbers: 3761, 7635, 7633, 7630, 7632, 7631.