# FDA recall Z-2592-2021

> **Atrium Medical Corporation** · Class II · device recall initiated 2021-08-26.

## Product

Atrium Pneumostat Chest Drain Valve, Part Number 16100

## Reason for recall

The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-2592-2021
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-26
- **Report date:** 2021-10-06

- **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-2592-2021

## Citation

> AI Analytics. FDA recall Z-2592-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2592-2021. Source: US FDA. Licensed CC0.

---

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