Maquet Sevoflurane vaporizer filling recalled due to potential hydrogen fluoride exposure
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane components in anesthesia systems due to potential chemical degradation that may cause hydrogen fluoride exposure via inhalation or skin contact.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Although the source does not report any illnesses, injuries, or deaths, the agency classification reflects the serious potential of hydrogen fluoride exposure in critical anesthesia systems requiring regulatory intervention.
Plain-English summary
Getinge Usa Sales Inc is recalling the Vaporizer Sevoflurane Maquet Filling (Part No. 6886601), a component of multiple anesthesia systems. The recall addresses a potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides), which may result in exposure to hydrogen fluoride through inhalation or skin contact.
The affected component is part of the Flow-c, Flow-e, and Flow-i Anesthesia System families. Specific serial numbers have been identified in the recall. Fifty units were distributed in the US, with documented distribution in Virginia and Missouri. An additional 898 units were distributed internationally across multiple countries.
Healthcare operators using these systems should identify potentially affected units by serial number and contact Getinge Usa Sales Inc for further instructions, inspection requirements, and replacement procedures.
The recalled product
- Product
- Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- hydrogen-fluoride-exposure
- chemical-degradation
Distribution
Distributed nationwide across the United States.
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