# FDA recall Z-1138-2022

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2022-04-26.

## Product

In-Line ventilator adaptor

## Reason for recall

There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

## Distribution

US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.

## Key facts

- **Recall number:** Z-1138-2022
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-26
- **Report date:** 2022-06-08
- **Termination date:** 2024-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2022

## Citation

> AI Analytics. FDA recall Z-1138-2022. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1138-2022. Source: US FDA. Licensed CC0.

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