AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife R...
FDA Device Recall #Z-1579-2018 — Class I — April 27, 2017
Recall Summary
| Recall Number | Z-1579-2018 |
| Classification | Class I — Serious risk |
| Date Initiated | April 27, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vyaire Medical |
| Location | Vernon Hills, IL |
| Product Type | Devices |
| Quantity | 150 units |
Product Description
AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
Reason for Recall
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
Distribution Pattern
Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
Lot / Code Information
Part Number: 7730POCH. Lots: 0000993427, 0001069517
Other Recalls from Vyaire Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1697-2025 | Class I | Brand Name: AirLife Product Name: AirLife Infa... | Apr 10, 2025 |
| Z-1698-2025 | Class I | Brand Name: AirLife Product Name: AirLife Infa... | Apr 10, 2025 |
| Z-1061-2024 | Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) O... | Jan 10, 2024 |
| Z-1065-2024 | Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) O... | Jan 10, 2024 |
| Z-1064-2024 | Class I | AirLife Adult Manual Resuscitator, Variable Vol... | Jan 10, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.