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.
FDA Recall Z-1074-2025 · Posted 2025-02-07
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Recalling FirmGetinge Usa Sales Inc
Recall StatusOpen, Classified
Product CodeBSZ
Date Initiated2025-01-15
Product Quantity6 units
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Domestic distribution to Kentucky and Connecticut.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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