Vyaire Medical Recall 93821
Description: AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Vyaire Medical Recall 93821 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1062-2024 |
| Event ID | 93821 |
| Event Description | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F |
| Product Type | Devices |
| Distribution | Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa |
| Quantity | 2,070 units |
| Recall Reason | 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. |
| Device Classification | 20240306 |
| Device Code Info | UDI/DI Case: 50190752114188, Each: 10190752114180; All manufacturing dates of 2017 and prior, and any products without a manufacturing date. |
| Center Classification Date | 20240224 |
| Recall Initiation Date | 20240110 |
| Recalling Firm | Vyaire Medical |
| Initial Notification | Letter |
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