Agency classClass IOur severity:Severe FDA (Devices)·Z-1458-2023·Announced 2023-05-24

Anesthesia Set Coax 180 Breathing Circuit Connection Risk

Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.

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 requires a minimum severity score of 4. The hazard—loose breathing circuit connections that could cause detachment and prevent proper ventilation during anesthesia—poses serious potential risk to patient safety, though no injuries or deaths have been reported.

Plain-English summary

Draeger Medical, Inc. is recalling the Anesthesia Set Coax 180 (Model MP03384), an anesthesia breathing circuit set. The recall affects 20 units that were distributed nationwide in the United States.

The breathing circuit connections are glued, and these connections can become loose before or during ventilation. Loose or partially detached connections in the breathing circuit could prevent proper ventilation during anesthesia administration.

The Food and Drug Administration classified this as a Class I recall due to the potential risk of patient harm from compromised ventilation. No injuries or illnesses related to this issue have been reported.

Healthcare providers who have received this product should discontinue use and contact Draeger Medical, Inc. for instructions regarding replacement or return of affected units.

The recalled product

Product: Anesthesia Set Coax 180, MP03384
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Anesthesia Equipment
Hazard: loose-connection
disconnection
ventilation-failure
Affected units: 20

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: 04048675552833
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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