| 2025-04-10 |
Class I
|
Ongoing |
Z-1698-2025 |
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/… |
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Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, in… |
| 2025-04-10 |
Class I
|
Ongoing |
Z-1697-2025 |
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/… |
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Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, in… |
| 2024-04-08 |
Class I
|
Ongoing |
Z-1730-2024 |
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used … |
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Potential of the nozzle separating during patient use. |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1065-2024 |
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004 |
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Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1064-2024 |
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017 |
— |
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1063-2024 |
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2 |
— |
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1062-2024 |
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F |
— |
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1061-2024 |
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005 |
— |
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1060-2024 |
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2 |
— |
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1059-2024 |
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F |
— |
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1058-2024 |
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001 |
— |
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2024-01-10 |
Class I
|
Ongoing |
Z-1057-2024 |
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, |
— |
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure ma… |
| 2023-10-27 |
Class II
|
Completed |
Z-0489-2024 |
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ven… |
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Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distribut… |
| 2023-10-27 |
Class II
|
Completed |
Z-0488-2024 |
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ven… |
— |
Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distribut… |
| 2023-05-05 |
Class II
|
Completed |
Z-1967-2023 |
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator |
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Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscr… |
| 2023-05-05 |
Class II
|
Completed |
Z-1966-2023 |
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator |
— |
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscr… |
| 2021-12-20 |
Class I
|
Terminated |
Z-0622-2022 |
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/10… |
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Potential cessation in ventilation can occur under specific conditions. |