# FDA recall Z-0316-2024

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

## Product

Ocean Water Seal Chest Drains (Ocean):  Products REF Number Product Name   (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S;   (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR;  (3)2002-100 DRAIN, OCEAN SINGLE W/AC;   (4)2002-300 DRAIN, OCEAN SINGLE W/S;   (5) 2002-400 DRAIN, OCEAN SINGLE ;  (6)2012-320 DRAIN, OCEAN PEDI W/S;  (7)2050-000 DRAIN, OCEAN BRU W/AC,S

## 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-0316-2024
- **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-0316-2024

## Citation

> AI Analytics. FDA recall Z-0316-2024. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0316-2024. Source: US FDA. Licensed CC0.

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