Agency classClass IOur severity:Severe FDA (Devices)·Z-1453-2023·Announced 2023-05-24

Anesthesia Circuit Kit Coax 3 Connections May Detach During Ventilation

Draeger Medical is recalling Anesthesia Circuit Kit Coax 3 units because glued connections can become loose or detach before or during ventilation. The recall covers 329,294 units distributed nationwide.

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 classification indicates serious patient safety risk. While the source text does not report any illnesses or injuries, the FDA's Class I designation establishes a minimum severity score of 4.

Plain-English summary

Draeger Medical, Inc. is recalling the Anesthesia Circuit Kit Coax 3 (model MP02732) due to a defect in the breathing circuit connections. The glued connections of the breathing circuit can become loose before or during ventilation, which may result in partial or complete detachment of pieces.

The recall affects 329,294 units distributed nationwide in the United States. All lots are included, identified by UDI-DI 04048675412038. This is a Class I medical device recall.

Healthcare facilities should immediately discontinue use of this product and contact Draeger Medical, Inc. for replacement units or return procedures. The FDA can provide additional information about this recall.

The recalled product

Product: Anesthesia Circuit Kit Coax 3, MP02732
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Anesthesia Equipment
Hazard: loose-connection
circuit-detachment
Affected units: 329,294

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: 04048675412038
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 connection