AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
Summary
The FDA issued a Class I for AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detecto by Vyaire Medical. Reason: Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device .
Details
Source
Device Recall
External ID
Z-1060-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
Lot/Code Info: UDI/DI Case: 50190752114119, Each: 10190752114111; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
Quantity Affected: 3,636 units
Reason for Recall
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Distribution
Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-10
Company
Mettawa, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Vyaire Medical has 16 FDA actions in our database, including 16 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vyaire Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vyaire Medical have FDA actions?
Vyaire Medical has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1060-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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