This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
This is an expansion of the 2024 Class I Recall: Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
Affected Product
- Product Names: Vaporizer Sevoflurane Maquet Filling, Vaporizer Sevoflurane, Quick-Fil
- Unique Device Identifier (UDI)/Model:
- Maquet Filling: 07325710000212/6682282*
- Quick-Fil: 07325710001141/6682285
- Serial Numbers:
- Maquet Filling: 17336 – 23784* and all serial numbers greater than 1339
- Quick-Fil: All serial numbers greater than 3761
*These devices were included in the original recall.
What to Do
- Do not use any affected vaporizer if it may have ever been used with Sevoflurane Piramal or Baxter Sevoflurane.
- Do not leave sevoflurane in any Getinge vaporizer for longer than 30 days or during external transportation.
- Make sure any Getinge vaporizer containing sevoflurane has been used within the last 30 days.
- Do not empty any vaporizer with signs of discoloration or corrosion, or with an unusual smell.
- Empty and dry-run (see below) Getinge vaporizers containing sevoflurane if they have not been used in the last 30 days and there are no signs of corrosion or discoloration.
On January 15, 2025, Getinge and its subsidiary Maquet Critical Care AB, sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Quarantine all affected product.
- Do not empty any vaporizer used with sevoflurane that has signs of discoloration or corrosion, or with an unusual smell. Use protective gloves, goggles and use general chemical handling safety guidelines when moving the vaporizer for storage.
- If there are no signs of discoloration or corrosion within the vaporizer or an unusual smell, empty it and perform dry run instructions (included in the letter and the instructions for use) as follows:
- Reinsert the Vaporizer: After emptying the vaporizer following the instructions in the user manual, reinstall it into the Flow Family anesthesia system.
- Initiate Manual Mode: Start a case and set the Flow Family anesthesia system to Manual mode.
- Adjust Gas Flow: Increase the fresh gas flow to 20 liters per minute (l/min).
- Set Sevoflurane Concentration: Adjust the sevoflurane concentration to 8%.
- Dry-Run Process: Allow the system to run for 5 minutes to ensure the vaporizer is completely emptied.
- Remove or Refill: After the dry run is complete, remove the empty vaporizer from the anesthesia system. Either store it or refill it with fresh sevoflurane if immediate use is required.
- Contact the local Getinge representative or email Sales Support at CSalesSupport@getinge.com to request a return authorization (RMA) and shipping instructions for return of empty affected product.
- Ask the Getinge representative for specific instructions related to the return of vaporizers with signs of discoloration/corrosion if needed.
- Forward the notice to anyone who needs to be aware, whether inside the organization or at any other facility where affected devices have been transferred.
- Complete and sign the Urgent Medical Device Recall Response Form attached to the letter, even if no affected product is present.
Reason for Recall
Getinge is recalling the Vaporizer Sevoflurane Maquet Filling and Vaporizer Sevoflurane Quick-Fil after receiving reports of discoloration and/or corrosion within the vaporizer after it was used with low water content sevoflurane manufactured by Piramal or Baxter. Sevoflurane used in the vaporizer may degrade to hydrogen fluoride. This toxic and hazardous acid may present a risk to both patients and health care professionals if it is inhaled or comes into contact with the skin. This is an expansion of an earlier recall.
The use of affected product may cause serious adverse health consequences, including irritation of respiratory tract leading to fluid buildup in the lungs (lung edema) and/or severely low levels of calcium in the blood (hypocalcemia), blistering, skin wounds (superficial ulceration), low levels of magnesium in the blood (hypomagnesemia), and death.
There have been no reported injuries and no reports of death.
Device Use
Vaporizers Sevoflurane Maquet Filling and Sevoflurane Quick-Fil are part of the Flow anesthesia systems. These vaporizers are used exclusively for containing, vaporizing, and blending liquid sevoflurane with oxygen to start and maintain general anesthesia. The manufacturers Abbvie, Baxter, and Piramal produce different formulations of sevoflurane.
Contact Information
Customers in the U.S. with questions about this recall should contact the local Getinge representative or email Sales Support at CCSalesSupport@getinge.com.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
-
Content current as of:
03/03/2025
