Anesthesia Ventilator Breathing Circuit Connections May Detach During Use
Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.
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 FDA Class I recall involves a structural defect in a critical anesthesia delivery device. Although no illnesses or injuries have been reported, the potential for serious patient harm from improper anesthesia delivery during surgery warrants the Class I designation and minimum score of 4.
Plain-English summary
Draeger Medical, Inc. is recalling 130 units of the VentStar Anesthesia WT (P)180, MP00374 anesthesia ventilator distributed nationwide in the United States.
The ventilators contain a defect in which glued connections of the breathing circuit can become loose before or during ventilation, resulting in partial or complete detachment of circuit components.
A loose or detached breathing circuit connection could impair or prevent the delivery of anesthesia during surgical procedures. This creates a risk of serious patient harm.
Healthcare facilities using this device should discontinue use and contact Draeger Medical, Inc. for repair, replacement, or return instructions.
The recalled product
- Product
- VentStar Anesthesia WT (P)180, MP00374
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- connection-failure
- breathing-circuit-detachment
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: 04048675421948
- All lots.
Distribution
Distributed nationwide across the United States.
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