Sevoflurane Vaporizer Quik-Fil Recalled Due to Chemical Degradation Risk
A sevoflurane vaporizer component may degrade to hydrogen fluoride, causing respiratory damage and chemical burns to patients and workers. FDA classified this Class I recall affecting six units in Kentucky and Connecticut.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is FDA Class I medical device recall, which requires minimum severity score of 4. No illnesses or injuries have been reported despite the potential for serious respiratory and systemic harm from hydrogen fluoride exposure.
Plain-English summary
The FDA is recalling six units of the Sevoflurane Vaporizer, Quik-Fil (Model 6682285), a component of anesthesia delivery systems. The affected units are identified by serial numbers 3761, 7635, 7633, 7630, 7632, and 7631 and were distributed to healthcare facilities in Kentucky and Connecticut. The vaporizer is manufactured by Getinge Usa Sales Inc.
Sevoflurane used with this vaporizer may degrade into hydrogen fluoride, which can be inhaled or absorbed through skin contact. This presents a potential risk to patients undergoing anesthesia and to healthcare providers in the operating room.
Exposure to hydrogen fluoride may cause irritation of the respiratory tract, which in worst-case scenarios may lead to lung edema and severe hypocalcemia. Skin contact may result in blistering, superficial ulceration, and hypomagnesemia.
The recalled product
- Product
- 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.
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model Number: 6682285. UDI-DI: 07325710001141. Serial Numbers: 3761
- 7635
- 7633
- 7630
- 7632
- 7631.
Distribution
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