Airlife Adult Manual Resuscitator
Brand(s)
Last updated
Summary
Product
Airlife Adult Manual Resuscitator
Issue
Medical devices - Performance
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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