Draeger VentStar Breathing Circuit Connections May Loosen During Use
Draeger Medical is recalling the VentStar Bag Set because glued connections on the breathing circuit can become loose or detach during ventilation, potentially compromising respiratory support.
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: This is an FDA Class I recall, the most serious classification, which mandates a minimum severity score of 4. The defect involves glued breathing circuit connections that can become loose or completely detach during ventilation, which could compromise respiratory support. No illnesses or injuries have been reported, preventing a higher classification.
Plain-English summary
Draeger Medical, Inc. is recalling approximately 375 units of the VentStar Bag Set (Model N 110, MP00383) distributed nationwide in the United States.
The breathing circuit connections in this product are joined with glue that may become loose before or during ventilation. This can result in partial or complete detachment of the breathing circuit components during use.
The VentStar Bag Set is used during ventilation procedures. If breathing circuit connections detach during use, the integrity of the ventilation circuit is compromised, potentially affecting patient care.
This is a Class I recall issued by the U.S. Food and Drug Administration (FDA). Customers who have received this product should contact Draeger Medical, Inc. immediately regarding recall number Z-1450-2023.
The recalled product
- Product
- VentStar Bag Set (N) 110, MP00383
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 375
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: 04048675421887
- 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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