# FDA recall Z-0318-2024

> **Atrium Medical Corporation** · Class II · device recall initiated 2023-09-18.

## Product

Express Dry Seal Chest Drains (Express):    4000-100N DRAIN, EXPRESS, SINGLE;  4050-100N DRAIN, EXPRESS, BRU

## Reason for recall

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of  catheter(s) and patient tube connections with single collection chamber chest drains

## Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria,  Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel,  Italy, Jordan, Korea, Republic of Kuwait, Latvia, Lithuania, Luxembourg, Malaysia,  Malta, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan,  Peru, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore,  Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan Province of China, Thailand Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uruguay.

## Key facts

- **Recall number:** Z-0318-2024
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-18
- **Report date:** 2023-11-22

- **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-0318-2024

## Citation

> AI Analytics. FDA recall Z-0318-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0318-2024. Source: US FDA. Licensed CC0.

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