FDA-Device2021-12-01Class II
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.
Atrium Medical Corporation
Hazard
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
Sold states
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
Affected count
87,972 drains (14,662 cases; 6 units/case)
Manufactured in
40 Continental Blvd, Merrimack, NH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0307-2022Don't want to check this manually?
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