The Recall Desk
SevereFDA (Devices)·Z-1441-2023·Announced 2023-05-24

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.

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 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.
Hazard
  • circuit-detachment
  • equipment-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: 04048675422051
  • All lots.

Distribution

Distributed nationwide across the United States.