FDA-Device2023-04-05Class II
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Atrium Medical Corporation
Hazard
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
Sold states
Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand.
Affected count
3554 cases of 10
Manufactured in
40 Continental Blvd, N/A, Merrimack, NH, United States
Products
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2023Don't want to check this manually?
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