Getinge Usa Sales Inc: Medical Device Recall in 2024 - (Recall #: Z-1877-2024)

Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.

Class I

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.

Part Number 6682282; UDI/DI: 07325710000212: Serial Numbers: 17003 - 23454.

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, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macau, Macedonia, Malaysia, Mexico, Moldavia, Morocco, Mozambique, Namibia, Netherlands, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Vietnam Please note that a list of foreign consignees was not provided by the manufacturer and it is not available at this time.

Voluntary: Firm initiated