Express Mini 500 and Pneumostat Chest Drain Valve
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Express Mini 500 |
All lots. |
16400 |
Pneumostat Chest Drain Valve |
All lots. |
16100 |
Issue
The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 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. The notices for this recall give the appropriate precautions to the end users.
Recall start date: March 6, 2023
Additional information
Details
Atrium Medical Corporation
40 Continental Blvd., Merrimack, New Hampshire, United States, 03054
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