Food, drugs, devices › Getinge Usa Sales Inc
Device recall: Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow
Getinge Usa Sales Inc (Wayne, NJ) initiated this device recall on 9 Dec 2021; FDA lists 1 product record under event 89125, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Getinge Usa Sales Inc has 17 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Getinge Usa Sales Inc, Wayne, NJ.
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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0468-2022 | 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… | 50 US; 898 OUS | Class I | Ongoing | 19 Jan 2022 |
Context
Other enforcement events for Getinge Usa Sales Inc
All 17 events for Getinge Usa Sales Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.