Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flo
FDA device recall Z-1074-2025 · posted 2025-02-07 · Open, Classified
Recall details
- Recalling firm
- Getinge Usa Sales Inc
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- BSZ
- Quantity affected
- 6 units
- Distribution
- Domestic distribution to Kentucky and Connecticut.
- Date initiated
- 2025-01-15
- Date posted
- 2025-02-07
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (K191027) | Maquet Critical Care AB | 2020-03-18 |