Anesthesia Circuit Kit Coax 1 Recall: Breathing Circuit Connections May Loosen or Detach
Draeger Medical is recalling Anesthesia Circuit Kit Coax 1 (MP02730) because glued breathing circuit connections can become loose or detach during ventilation, affecting the breathing circuit's function.
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 recall is classified as FDA Class I. Per the severity rubric, FDA Class I recalls must receive a minimum score of 4 (Severe). The hazard involves potential disconnection of breathing circuit components during ventilation in an anesthesia setting, though no illnesses or injuries are reported.
Plain-English summary
Draeger Medical, Inc. is recalling Anesthesia Circuit Kit Coax 1 (MP02730) due to a defect in the breathing circuit connections. The product is used in anesthesia delivery systems during surgical procedures.
The glued connections of the breathing circuit can become loose before or during ventilation, resulting in partial or complete detachment of pieces. This defect could affect the function of the breathing circuit during use.
Approximately 200,900 units have been distributed across the United States across all lot numbers (UDI-DI: 04048675412014).
Users should contact Draeger Medical, Inc. regarding this recall for further information about the product and next steps.
The recalled product
- Product
- Anesthesia Circuit Kit Coax 1, MP02730
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 200,900
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: 04048675412014
- 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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