AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
Reported: March 6, 2024 Initiated: January 10, 2024 #Z-1060-2024
Product Description
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
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.
Details
- Recalling Firm
- Vyaire Medical
- Units Affected
- 3,636 units
- Distribution
- Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
- Location
- Mettawa, IL
Frequently Asked Questions
What product was recalled? ▼
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2. Recalled by Vyaire Medical. Units affected: 3,636 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2024. Severity: Critical. Recall number: Z-1060-2024.
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