Agency classClass IOur severity:Severe FDA (Devices)·Z-1457-2023·Announced 2023-05-24

Ventstar Coax 230 breathing circuit connections can detach during ventilation

The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.

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 medical device recall with a defect that can compromise critical breathing support equipment function. Although no injuries are reported in the source text, the Class I designation reflects reasonable probability of serious adverse health consequences.

Plain-English summary

Draeger Medical, Inc. is recalling the Ventstar Coax 230 (model MP03376) breathing circuit components due to a defect in glued connections.

The breathing circuit connections can become loose before or during ventilation. This loosening can result in partial or complete detachment of circuit pieces, which may compromise the delivery of ventilation support to patients.

This recall affects all lots of the Ventstar Coax 230. A total of 40 units have been identified as affected and distributed nationwide within the United States.

Healthcare facilities using this equipment should discontinue use and contact the manufacturer for replacement units or instructions. Patients currently on this equipment should consult with their healthcare provider.

The recalled product

Product: Ventstar Coax 230, MP03376
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Ventilator / Breathing Circuit
Hazard: detachment
equipment-failure
Affected units: 40

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: 04048675545613
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 →

Same manufacturer · Draeger Medical, Inc.

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Same hazard · detachment