Recall Z-1877-2024 ยท BSZ Gas-Machine, Anesthesia
Getinge Usa Sales Inc
Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
| Date | May 31, 2024 (initiated May 1, 2024) |
| 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 | Under Investigation by firm |
| Action | On May 1, 2024 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken by customer: Until further notice, do NOT use the Vaproizer with Sevoflurane provided by Poramal and Baxter Sevoflurane. Do NOT use the Vaporizer if it was ever used with Sevoflurane Piramal and/or Baxter Sevoflurane, even if it currently is used with AbbVie Ultane. Our records indicate that you have received the Vaporizer Sevoflurane, Maquet Filling having one or more of the serial numbers that are affected by this recall. 1. Please examine your inventory immediately to determine if you have any o |
| Quantity | 120 units (US) |
| Distribution | Domestic: CA, CO, IN, MO, OR, VA, WA. International: Aruba, Australia, Austria, Belgium, Bolivia, Bosnia-Herzegovina, Brazil, Bulgaria, Chile, China, Costa Rica, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jo |
| 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 |