The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Hazard
  • loose-connection
  • circuit-detachment

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.