Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)361...

FDA Device Recall #Z-0317-2024 — Class II — September 18, 2023

Recall Summary

Recall Number Z-0317-2024
Classification Class II — Moderate risk
Date Initiated September 18, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Atrium Medical Corporation
Location Merrimack, NH
Product Type Devices
Quantity 471037 cases US; 638 case OUS

Product Description

Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;

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 Pattern

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.

Lot / Code Information

UDI-DI: (1)3600-100 DRAIN, OASIS SINGLE W/AC 20650862110016; (2)3612-100 DRAIN, OASIS PEDI A/C 20650862111013; (3) 3650-100 DRAIN, OASIS BRU W/AC 20650862113017 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020

Other Recalls from Atrium Medical Corporation

Recall # Classification Product Date
Z-0024-2025 Class II iCast Covered Stent, 6MMx16MMx120CM, Model Numb... Sep 9, 2024
Z-1960-2024 Class II ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-End... May 3, 2024
Z-1951-2024 Class II ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-End... May 3, 2024
Z-1989-2024 Class II ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-End... May 3, 2024
Z-1954-2024 Class II ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-End... May 3, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.