# FDA recall Z-0307-2022

> **Atrium Medical Corporation** · Class II · device recall initiated 2021-10-22.

## Product

The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.

## Reason for recall

Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

## Distribution

US Nationwide Distribution  Foreign:  Bahrain  Belgium  Brunei Darussalam  Canada  Colombia  Ecuador  Finland  Italy  Kuwait  Libya  Mauritius  Mexico  Netherlands  Poland  Portugal  Russian Federation  Saudi Arabia  Spain  United Arab Emirates  United Kingdom of Great Britain and Northern Ireland

## Key facts

- **Recall number:** Z-0307-2022
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-22
- **Report date:** 2021-12-01

- **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-0307-2022

## Citation

> AI Analytics. FDA recall Z-0307-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0307-2022. Source: US FDA. Licensed CC0.

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