# FDA recall Z-1302-2023

> **Atrium Medical Corporation** · Class II · device recall initiated 2023-03-01.

## Product

Atrium Pneumostat Chest Drain Valve, Part Number 16100

## Reason for recall

The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.

## Distribution

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand.

## Key facts

- **Recall number:** Z-1302-2023
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-01
- **Report date:** 2023-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Merrimack, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2023

## Citation

> AI Analytics. FDA recall Z-1302-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1302-2023. Source: US FDA. Licensed CC0.

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