FDA Device recall Z-0468-2022
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia Syste…
- FDA Device
- Class I
- ongoing
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class I recall of Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia Syste… by Getinge Usa Sales, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0468-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-12-09 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Getinge Usa Sales |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI: 07325710008430 Serial Nos. 15580 15890 15924 16284 16637 16837 16970 15582 15891 15925 16285 16638 16840 16971 1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0468-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.