Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285.… recallZ-1074-2025 · Getinge Usa Sales Inc · initiated Jan 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Getinge Usa Sales Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
Getinge notified consignees on 01/15/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were provided additional information which is complementary to the existing user manual and were instructed to ensure all affected product inventory has been quarantined, consignees are entitled to credit/replacement, the recall information is forwarded to affected personnel and any customers if it was further distributed and complete and return the provided URGENT MEDICAL DEVICE RECALL RESPONSE FORM.
Recall details
- Recall number
- Z-1074-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 15, 2025
- Posted by the FDA
- Feb 7, 2025
- Recalling firm
- Getinge Usa Sales Inc
- Quantity
- 6 units
- Product code
- BSZ
- FDA submissions
- K191027
- Distribution
- Domestic distribution to Kentucky and Connecticut.
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.
Code information (models, lots, serial numbers)
Model Number: 6682285. UDI-DI: 07325710001141. Serial Numbers: 3761, 7635, 7633, 7630, 7632, 7631.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vaporizer Sevoflurane, QUIK FIL 6682285Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall0 reports
Other devices under the same FDA submission
6 devices cleared under K191027 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Flow-c Anesthesia System 6887700Maquet Critical Care AB · Gas-Machine, Anesthesia6 recalls72 reports
- Flow-e Anesthesia System 6887900Maquet Critical Care AB · Gas-Machine, Anesthesia5 recalls19 reports
- Flow-i C20 Anesthesia System 6888520Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall2 deaths88 reports
- Flow-i C30 Anesthesia System 6888530Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall13 reports
- Flow-i C40 Anesthesia System 6888540Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall9 reports
- Vaporizer Sevoflurane, MAQUET filling 6886601Maquet Critical Care AB · Gas-Machine, Anesthesia1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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