Express Mini 500 and Pneumostat Chest Drain Valve
Brand(s)
Last updated
Summary
Product
Express Mini 500 and Pneumostat Chest Drain Valve
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
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
Original published date: 2023-03-15
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies
Atrium Medical Corporation
40 Continental Blvd., Merrimack, New Hampshire, United States, 03054
Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-73332