Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure
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.
- Product Names: Vaporizer Sevoflurane, Maquet Filling for Flow Family Anesthesia Systems
- Model Number: Model 6886601
- Manufacturing Dates: December 15, 2020 to July 21, 2021
- Distribution Dates: February 16, 2021 to October 30, 2021
- Devices Recalled in the U.S.: 50
- Date Initiated by Firm: December 9, 2021
The Vaporizer is a component of several Maquet anesthesia gas machines. The Flow Family of Anesthesia System administers inhalation anesthesia while controlling the entire ventilation of patients who are unable to breathe, as well as in supporting patients with a limited ability to breathe.
Reason for Recall
Getinge is recalling the Vaporizer Sevoflurane Maquet filling due to the potential chemical breakdown of Sevoflurane, a general surgical anesthetic, that may result in inhalation and/or skin exposure to harmful chemicals. If this occurs, this may cause serious patient harms including irritation of the respiratory tract, lung edema (swelling caused by excess fluid), and severe hypocalcemia (condition in which the blood has too little calcium).
There have been eight complaints regarding this device issue. There have been no reported deaths or injuries.
Who May Be Affected
- Health care providers using Getinge Vaporizer Sevoflurane, Maquet Filling for Flow Family Anesthesia Systems
- Patients receiving care using Getinge Vaporizer Sevoflurane, Maquet Filling for Flow Family Anesthesia Systems
What to Do
On December 9, 2021, Getinge sent an Urgent Medical Recall Letter to affected customers informing them of the product issue and potential risks to health.
Getinge asked customers to take the following actions:
- Examine their inventory and remove any affected products.
- Be aware:
- If they have the affected products they may receive a credit or replacement; however, replacements for use with Sevoflurane from Baxter and Piramal will be delayed.
- If they use agents from AbbVie ONLY, they can be provided a replacement Vaporizer, Model 6886601, by certifying use of AbbVie agents only on the Medical Device Recall Response Form (provided in the notification letter from Getinge).
- Be aware:
- Contact Getinge Customer Service at 888-943-8872 (press option 2) to request a return authorization (RMA) and shipping instructions to return any affected products.
- Pack the products 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 the RMA number provided by Customer Service in the spaces provided on the Medical Device Recall Response Form.
- If they do not have affected products, they should still complete and sign the Medical Device Recall Response Form. Return the completed form to Getinge by e-mailing a scanned copy to email@example.com or by faxing the form to 866-578-5809.
- Share this information with all current and potential Vaporizer Sevoflurane, Maquet filling users within their hospital or facility.
- If they are a distributor who has shipped any affected products to customers, forward this document to their attention for appropriate action.
Getinge provided the following recommendations:
- If at any time, the user notices the agent in the vaporizer looks cloudy or yellowish and there is a sweet-smelling pungent odor, the user should immediately stop use of the affected vaporizer.
- To prevent exposure, the user should be able to successfully perform a System Check-Out (SCO) procedure which may detect the failure prior to usage. If the gas analyzer test fails, a dialog box will appear to promptly inform the user.
Customers with questions about this recall should contact Getinge Customer Service by telephone at 888-943-8872 or email at firstname.lastname@example.org.
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.