VentStar Basic ventilator breathing circuit connections may detach
Draeger Medical is recalling 200 units of the VentStar Basic ventilator due to glued breathing circuit connections that can loosen or detach before or during ventilation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for a life-support medical device defect. Although no illnesses or injuries are reported in the source, the structural failure of a ventilator breathing circuit presents serious risk and the Class I designation establishes a minimum score of 4.
Plain-English summary
Draeger Medical, Inc. is recalling 200 units of the VentStar Basic (P)250 ventilator (Model MP00352). The recall affects all lots of this device (UDI-DI: 04048675422051).
The breathing circuit in these ventilators has glued connections that can become loose before or during ventilation, potentially resulting in partial or complete detachment of circuit pieces.
The devices were distributed nationwide throughout the United States. For information about this recall, affected parties should contact Draeger Medical, Inc.
The recalled product
- Product
- VentStar Basic (P)250, MP00352
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 200
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: 04048675422051
- 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.
See all 22 products in this recall →Related recalls
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