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.
Reported: February 19, 2025 Initiated: January 15, 2025 #Z-1074-2025
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.
Details
- Recalling Firm
- Getinge Usa Sales Inc
- Units Affected
- 6 units
- Distribution
- Domestic distribution to Kentucky and Connecticut.
- Location
- Wayne, NJ
Frequently Asked Questions
What product 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.. Recalled by Getinge Usa Sales Inc. Units affected: 6 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2025. Severity: Critical. Recall number: Z-1074-2025.
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