Health product recall

Airlife Adult Manual Resuscitator

Last updated

Summary

Product
Airlife Adult Manual Resuscitator
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Airlife Adult Manual Resuscitator

All lots.

2K8004
2K8005F
2K8017
2K8000
2K8004F
2K8004C2
2K8005C2
2K8005

Issue

Vyaire has received thirty-seven (37) customer reports relating to product issues, including two deaths and two serious injuries. It has been identified that the affected product issues are due to faulty mold/tooling producing out of specification components. This device failure may result in improper ventilation or no ventilation that may result in hypo-ventilation or hypoxia, and potentially may lead to death. 

Recall Start Date: January 10, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Vyaire Medical, Inc.

26125 N. Riverwoods Blvd., Mettawa, Illinois, United States, 60045

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75349

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