Reported Aug 15, 2018 · Terminated
AirLife Resuscitation Device, Pediatric 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, Pediatric labeled as the following
4 of 4 products
| Model / number | Product as published |
|---|---|
2K8018 | Pediatric, with mask, 28" large bore tubing, pressure-relief valve |
2K8008 | Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve |
RE1DK5445D | Pediatric, Resuscitation kit with neonatal, infant and pediatric masks |
2K8039 | Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, 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. |
- Lot codes and dates
a. Part Number 2K8018Lot Number 0001210201b. Part Number 2K8008 Lot Numbers 00012098310001209837c. Part Number RE1DK5445DLot Numbers 00040025630004003205d. Part Number 2K8039Lot Number 0001209839
- 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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