Recall Z-1074-2025 ยท BSZ Gas-Machine, Anesthesia
Getinge Usa Sales Inc
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.
| Date | Feb 7, 2025 (initiated Jan 15, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 6 units |
| Distribution | Domestic distribution to Kentucky and Connecticut. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Maquet Critical Care AB, Mar 18, 2020 |