The Recall Desk
SevereFDA (Devices)·Z-1456-2023·Announced 2023-05-24

Breathing circuit component connections may become loose during ventilation

Draeger Medical recalls ID Coax 180 breathing circuit components due to glued connections that can become loose or detach during ventilation.

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: This is an FDA Class I recall of a critical breathing circuit component. Although no injuries or deaths are reported in the source text, the potential for connection detachment during ventilation poses a serious risk of patient harm. FDA Class I classification establishes a minimum severity floor of 4.

Plain-English summary

Draeger Medical, Inc. is recalling the ID Coax 180 (model MP03375) breathing circuit component. The product was distributed nationwide in the United States.

The breathing circuit connections are joined using adhesive. These glued connections can become loose before or during ventilation, which may result in partial or complete detachment of circuit pieces. Detachment of breathing circuit components during ventilation could compromise patient ventilation.

The recall affects all units of the ID Coax 180, identified by UDI-DI 04048675545590, across all manufacturing lots. Twenty units were distributed.

Healthcare facilities and providers who have received this product should contact Draeger Medical, Inc. for further instructions regarding affected units.

The recalled product

Product
ID Coax 180, MP03375
Manufacturer
Draeger Medical, Inc.
Hazard
  • breathing-circuit-detachment
  • connection-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: 04048675545590
  • All lots.

Distribution

Distributed nationwide across the United States.