Home / Recalls / Getinge Usa Sales Inc / Z-1877-2024

Z-1877-2024 Class I Ongoing

Recalled by Getinge Usa Sales Inc — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
June 12, 2024
Initiation Date
May 1, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 units (US)

Product Description

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

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.

Distribution Pattern

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.

Code Information

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

Other recalls by Getinge Usa Sales Inc

  • Z-1074-2025 Class I — Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component o (January 15, 2025)
  • Z-0463-2025 Class II — MEERA CL mobile operating table - Designed for the placement and positioning of (October 3, 2024)
  • Z-0457-2025 Class II — MEERA CL mobile operating table - Designed for the placement and positioning of (October 3, 2024)
  • Z-0461-2025 Class II — MEERA CL mobile operating table - Designed for the placement and positioning of (October 3, 2024)
  • Z-0456-2025 Class II — MEERA CL mobile operating table - Designed for the placement and positioning of (October 3, 2024)
  • Z-0458-2025 Class II — MEERA CL mobile operating table - Designed for the placement and positioning of (October 3, 2024)
  • Z-0460-2025 Class II — MEERA CL mobile operating table - Designed for the placement and positioning of (October 3, 2024)
  • Z-0459-2025 Class II — MEERA CL mobile operating table - Designed for the placement and positioning of (October 3, 2024)
  • Z-0462-2025 Class II — MEERA CL mobile operating table - Designed for the placement and positioning of (October 3, 2024)
  • Z-2271-2024 Class II — ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 (May 29, 2024)