Getinge Usa Sales Inc Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anesthesia Syst Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.

Recommended Action

Per FDA guidance

On December 9, 2021, the firm began distribution of Urgent Medical Device Recall letters to affected customers. Customers were informed of the product issue and potential risks to health, which may include irritation of respiratory tract and in worst case may lead to lung edema and/or severe hypocalcemia which may be delayed for 24-48 hours after exposure. Actions to be taken by the Customer: " Please examine your inventory immediately to determine if you have any of the Vaporizer Sevoflurane, Maquet Filling with the product codes/serial numbers listed in this notice. " Should you have any affected product, please remove from areas of use. " If you have affected product you are entitled to a credit or replacement; however, replacements for use with Sevoflurane from Baxter and Piramal will not be available for some time. " If you use agents from AbbVie ONLY, you can be provided a replacement Vaporizer, Model 6886601, by certifying use of AbbVie agents only on the Medical Device Recall Response Form on page 5. " Please 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. " Please enter the serial number and your RMA number provided by Customer Service in the spaces provided on the Medical Device Recall Response Form on Page 5 of this letter. " If at any time, should the user notice that the agent in the vaporizer looks cloudy and yellowish and/or detect 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 t