Agency classClass IOur severity:Severe FDA (Devices)·Z-1450-2023·Announced 2023-05-24

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.

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: 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.
Category: Medical Device — Breathing Circuit Equipment
Hazard: loose-connections
circuit-detachment
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.

See all 22 products in this recall →

Same manufacturer · Draeger Medical, Inc.

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Same hazard · loose connections