Vaporizer Sevoflurane Maquet Filling — Class I medical device recall Z-0468-2022
Ongoing recall by Getinge Usa Sales Inc, reported 2022-01-19, distributed nationwide. A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been disco
| Recall number | Z-0468-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2021-12-09 |
| Classified | 2022-01-10 |
| Reported by FDA | 2022-01-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BG, BH, BO, BR, CL, CN, CO, EE, GB, IL, IQ, IT, JP, KE, MA, MX, MY, NI, NO, OM, PE, PK, PL, PT, PY, SA, SG, TH, TN, TR, TT, VN, ZA |
| Reason classes | chemical contamination, specification failure |
| UPC / GTIN / UDI-DI | 07325710001318, 07325710001349, 07325710008430, 07325710009765, 07325710010457, 07325710010617, 07325710010624, 07325710010631 |
| Serial numbers | 15580, 15582, 15721, 15722, 15725, 15726, 15728, 15729, 15731, 15732, 15890, 15891, 15894, 15914, 15917, 15919, 15920, 15921, 15922, 15923, 15924, 15925, 16268, 16269, 16270 and 37 more |
| Model numbers | 6886601 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0468-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.