Class 1 Device Recall Vaporizer Sevoflurane, Maquet Filling

• Date Initiated by Firm: December 09, 2021
• Create Date: January 10, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0468-2022
• Recall Event ID: 89125
• 510(K)Number: K191027
• Product Classification: Gas-machine, anesthesia - Product Code BSZ
• Product: 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 System 6677400 07325710001318
• Code Information: UDI: 07325710008430 Serial Nos. 15580 15890 15924 16284 16637 16837 16970 15582 15891 15925 16285 16638 16840 16971 15721 15894 16268 16345 16639 16842 15722 15914 16269 16352 16640 16843 15725 15917 16270 16354 16690 16844 15726 15919 16271 16632 16828 16961 15728 15920 16272 16633 16832 16964 15729 15921 16273 16634 16833 16965 15731 15922 16276 16635 16834 16966 15732 15923 16283 16636 16836 16968
• Recalling Firm/ Manufacturer: Getinge Usa Sales Inc; 1 Geoffrey Way; Wayne NJ 07470-2035
• For Additional Information Contact: Stephanie Moretti; 973-709-7170
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 50 US; 898 OUS
• Distribution: Worldwide distribution - US Nationwide distribution in the states of VA and MO. The countries of Austria, Bahrain, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Estonia, Iraq, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Morocco, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BSZ