Recall Z-0468-2022 ยท BSZ Gas-Machine, Anesthesia
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 6
| Date | Dec 9, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 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, Port |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Maquet Critical Care AB, Mar 18, 2020 |