VentStar Breathing Bag Set Recalled for Loose Circuit Connections
Draeger Medical is recalling VentStar breathing bag sets nationwide due to loose glued connections in the breathing circuit. Connections can detach before or 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 Class I medical device recall. The hazard involves glued connections that can detach during use in a breathing apparatus, a critical respiratory device. Class I classification mandates a minimum severity score of 4.
Plain-English summary
Draeger Medical, Inc. is recalling VentStar breathing bag Set (P) 110, model MP00384. This device is distributed nationwide in the United States, with all production lots affected.
The glued connections of the breathing circuit can become loose before or during ventilation. This may result in partial or complete detachment of circuit pieces.
The FDA has classified this as a Class I recall, indicating the seriousness of this defect in a critical medical device.
The recalled product
- Product
- VentStar breathing bag Set (P) 110, MP00384
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 25
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: 04048675421870
- All lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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