# FDA recall Z-0468-2022

> **Getinge Usa Sales Inc** · Class I · device recall initiated 2021-12-09.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0468-2022
- **Recalling firm:** Getinge Usa Sales Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-09
- **Report date:** 2022-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0468-2022

## Citation

> AI Analytics. FDA recall Z-0468-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0468-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*