The Recall Desk
SevereFDA (Devices)·Z-1460-2023·Announced 2023-05-24

Anesthesia circuit kit may detach during ventilation due to loose glued connections

Draeger Medical is recalling its Anesthesia Circuit Kit Coax HEPA (720 units) because glued connections can become loose during ventilation, potentially causing partial or complete detachment that could interrupt oxygen delivery during surgery.

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 recall. Although no illnesses or injuries have been reported, the defect poses a serious safety risk—circuit detachment during anesthesia could interrupt oxygen and anesthetic gas delivery, creating a life-threatening patient care interruption.

Plain-English summary

Draeger Medical, Inc. is recalling its Anesthesia Circuit Kit Coax HEPA, model MP17102 (UDI-DI: 04048675695622). The recall affects 720 units distributed throughout the United States. This medical device is used during anesthesia to deliver oxygen and anesthetic gases to patients.

The FDA has classified this as a Class I recall because the glued connections in the breathing circuit can become loose before or during ventilation. This may result in partial or complete detachment of circuit pieces, potentially interrupting the delivery of oxygen and anesthetic gases during surgery.

Healthcare facilities and anesthesia providers using this product should immediately discontinue use to prevent the risk of circuit detachment during patient care.

The recalled product

Product
Anesthesia Circuit Kit Coax HEPA, MP17102
Manufacturer
Draeger Medical, Inc.
Hazard
  • circuit-detachment
  • equipment-failure

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: 04048675695622
  • All lots.

Distribution

Distributed nationwide across the United States.