Agency classClass IOur severity:Critical FDA (Devices)·Z-0737-2019·Announced 2019-01-30

Draeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error

Draeger Medical is recalling 170 units of VentStar Basic 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuiting.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

Draeger Medical, Inc. is recalling 170 units of VentStar Basic 250 breathing circuits, catalog number MP00350. These devices are intended for single use to conduct respiratory gases between an anesthesia machine or ventilator and a patient. The recall covers both versions of the circuit, with and without water traps.

The recall was initiated because the breathing circuits were incorrectly pre-assembled. This defect creates a potential for incorrect connection or short circuiting of the breathing circuit. The agency has classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

The affected units were distributed in the United States to the states of Alabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina, and Texas. All lots are included in this recall. Healthcare facilities and consumers should stop using these devices immediately and contact Draeger Medical for instructions on return or replacement.

The recalled product

Product: VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets…
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Anesthesia Equipment
Hazard: incorrect-assembly
connection-error
Affected units: 170

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 (1)

All Lots

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Same manufacturer · Draeger Medical, Inc.

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