# FDA recall Z-3091-2024

> **Smiths Medical ASD Inc.** · Class I · device recall initiated 2024-05-31.

## Product

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

## Reason for recall

Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-3091-2024
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-31
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3091-2024

## Citation

> AI Analytics. FDA recall Z-3091-2024. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-3091-2024. Source: US FDA. Licensed CC0.

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