Reported Aug 15, 2018 · Terminated
AirLife Resuscitation Device, Adult labeled as the following
Vyaire Medical
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vyaire Medical · 26125 N Riverwoods Blvd · Mettawa, IL · 60045-3420
Is this the product you have?
AirLife Resuscitation Device, Adult labeled as the following
8 of 8 products
| Model / number | Product as published |
|---|---|
2K8004 | Adult, with mask, oxygen reservoir bag |
2K8035C2 | Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve |
2K8017 | Adult, with mask, 28" large bore tubing |
2K8005 | Adult, with mask, 40" oxygen reservoir tubing |
2K8036 | Adult, with mask, 40" oxygen reservoir tubing, PEEP valve |
2K8001 | Adult, without mask, 40" oxygen reservoir tubing |
2K8035M | Adult, with mask, oxygen reservoir bag, manometer, PEEP valve |
2K8004C2 | Adult, with mask, oxygen reservoir bag, CO2 detector, ; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation. |
- Amount recalled
- 15,714 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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