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.
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: 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.
- 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: 04048675545590
- 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.
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