Ventilation Device Recall: Set2Go Ventilation 12 Breathing Circuit Connections May Loosen
Draeger Medical is recalling Set2Go Ventilation 12 devices due to defective glued connections in the breathing circuit that can loosen or detach during ventilation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, which requires a minimum score of 4 per the rubric. The mechanical defect creates risk of interrupted ventilation during patient care. However, no illnesses or injuries have been reported, precluding a Critical rating.
Plain-English summary
Draeger Medical, Inc. is recalling the Set2Go Ventilation 12 (A), model MP07968 (UDI-DI: 04048675544739). This recall affects all manufacturing lots of the device, with approximately 500 units distributed nationwide throughout the United States.
The device contains defective glued connections in the breathing circuit. These connections can become loose before or during patient ventilation, potentially resulting in partial or complete detachment of circuit components. If disconnection occurs during ventilation, it may interrupt the delivery of oxygen and ventilated gases to the patient.
Healthcare facilities and medical professionals using this device should contact Draeger Medical, Inc. for further instructions on corrective actions, including options for repair, replacement, or device return.
The recalled product
- Product
- Set2Go Ventilation 12 (A), MP07968
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- breathing-circuit-disconnection
- connection-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04048675544739
- All lots.
Distribution
Distributed nationwide across the United States.
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