The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: Vaporizer Sevoflurane Maquet Filling
- Product Code: 6682282
- Distributed Serial Numbers: 17003 – 23454
- Devices Recalled in the U.S.: 120
- Dates Distributed: February 2, 2022 to March 29, 2024
- Date Initiated by Firm: April 24, 2024
Device Use
The Vaporizer Sevoflurane Maquet Filling is part of the Flow anesthesia systems, including Flow-i C20, C30, and C40 as well as Flow-c and Flow-e. The Vaporizer Sevoflurane is 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.
Reason for Recall
Getinge is recalling the Vaporizer Sevoflurane Maquet Filling after receiving reports of discoloration and/or corrosion within the vaporizer after Vaporizer Sevoflurane Maquet Fill 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.
Inhaling hydrogen fluoride can cause irritation of respiratory tract, leading to fluid buildup in the lungs (lung edema) and/or severely low levels of calcium in the blood (hypocalcemia). Hydrogen fluoride on the skin may cause blistering, skin wounds (superficial ulceration), and/or low levels of magnesium in the blood (hypomagnesemia). Use of these devices may cause serious injuries, serious health consequences, or death.
Getinge reports there have been two incidents and no injuries or deaths related to this issue.
Who May Be Affected
- Patients who are administered anesthesia with Vaporizer Sevoflurane Maquet Filling.
- Health care professionals who administer anesthesia with Vaporizer Sevoflurane Maquet Filling.
What to Do
On May 1, 2024, Getinge issued an Urgent Medical Device Removal letter to customers instructing them to stop use of the Vaporizer with Sevoflurane provided by Piramal and Baxter Sevoflurane. It also instructed users not to use the Vaporizer if it was ever used with Sevoflurane Piramal and/or Baxter Sevoflurane, even if it is currently not being used with these products. Additional actions were as follows:
- Examine inventory immediately to determine if the affected product is present.
- The Product Code/REF Number and serial number are found on the label located underneath each vaporizer.
- Remove any affected product from use.
- Vaporizers with the identified product code and serial numbers (6682282, serial numbers 17003-23454) may continue to be used with AbbVie Ultane after certifying use of AbbVie Ultane on the Medical Device Recall Response Form included with the letter, as outlined in a prior recall.
- Discontinue use of a vaporizer if it is uncertain whether it was used with Piramal Sevoflurane and/or Baxter Sevoflurane.
- Immediately stop use of an affected vaporizer if the agent looks cloudy and yellowish at any time.
- Credit or replacement will be given to customers with affected product.
- Contact Getinge Customer Service at 888-943-8872 (press option 2) to request a return authorization (RMA) and shipping instructions to return any affected product.
- Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider.
- Enter the serial number and your RMA number provided by Customer Service in the spaces provided on the Medical Device Recall Response Form included with the letter.
Contact Information
Customers with questions should contact call the Getinge Customer Support at 888-943–8872 (select option 2).
Additional Resources
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 using an online form, regular mail, or FAX.
