CLASS I ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report
Vaporizer Sevoflurane, Quik-Fil recalled by Getinge Usa Sales
Getinge Usa Sales is recalling Vaporizer Sevoflurane, Quik-Fil, distributed in Connecticut, Kentucky. The recall was initiated on 15 Jan 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1074-2025
- FDA event ID
- 96083
- Recalling firm
- Getinge Usa Sales, Wayne, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 15 Jan 2025
- FDA classified
- 7 Feb 2025
- Reported
- 19 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Jan 2025 | Recall initiated by company | |
| 7 Feb 2025 | Classified by FDA | +23 days |
| 19 Feb 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Domestic distribution to Kentucky and Connecticut.
Questions about this recall
Why was it 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 lots are affected?
Model Number: 6682285. UDI-DI: 07325710001141. Serial Numbers: 3761, 7635, 7633, 7630, 7632, 7631.
Where was it sold?
Domestic distribution to Kentucky and Connecticut.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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