Health product recall

Express Mini 500 and Pneumostat Chest Drain Valve

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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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