Sevoflurane Vaporizer Component Recall Due to Hydrogen Fluoride Degradation
Getinge's sevoflurane vaporizer component may degrade into hydrogen fluoride, posing inhalation and skin exposure risks to healthcare workers and patients. The FDA Class I recall affects 120 units distributed across six U.S. states.
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: FDA Class I classification establishes a minimum severity of 4 (Severe). Although no illnesses or injuries are reported in the source text, the hydrogen fluoride hazard involves serious potential effects including respiratory tract damage, lung edema, and chemical burns, confirming a Severe classification.
Plain-English summary
Getinge Usa Sales Inc is recalling a sevoflurane vaporizer component (Product Code 6682282) used in anesthesia delivery systems, specifically components of the Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, and Flow-e vaporizers. A total of 120 units were distributed in the United States across California, Colorado, Indiana, Missouri, Oregon, Virginia, and Washington, with additional units distributed internationally.
The sevoflurane liquid used in these vaporizers may degrade into hydrogen fluoride. This chemical poses a hazard through inhalation and skin exposure. Inhalation can cause irritation of the respiratory tract, and in severe cases, lung edema (accumulation of fluid in the lungs) and serious electrolyte imbalances including severe hypocalcemia (dangerously low blood calcium) and hypomagnesemia (low blood magnesium). Skin contact may result in blistering and superficial ulceration.
Healthcare providers and patients who use these vaporizers may face exposure to hydrogen fluoride and its effects. The U.S. Food and Drug Administration has classified this as a Class I recall due to the seriousness of the potential hazard.
The recalled product
- Product
- Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 120
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 (2)
- Part Number 6682282
- UDI/DI: 07325710000212: Serial Numbers: 17003 - 23454.
Distribution
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