The Recall Desk
ModerateFDA (Devices)·Z-2719-2024·Announced 2024-09-04

Cobra EMG ET Tube Recalled Due to Incorrect Size Labeling

Neurovision Medical Products recalls Cobra 3-Plate EMG ET Tubes due to mislabeling with incorrect tube size on the label. The error could affect proper product selection in clinical procedures.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II medical device with a labeling error and no reported illnesses or injuries. This meets the rubric criterion for 'minor labeling errors' and represents a precautionary recall.

Plain-English summary

Neurovision Medical Products Inc is recalling the Cobra 3-Plate EMG ET Tube, 6.0mm (REF: LTE7003PM). This is an endotracheal tube used for electromyography monitoring during intubation procedures as part of an EMG RLN monitoring kit.

The recall is due to mislabeling. The labeling on the EMG RLN monitoring kit contains an incorrect tube size designation, which could lead to use of the wrong tube size in clinical procedures.

Lot 051724B (UDI: B006LTE7003PS52) is affected, comprising 5 boxes with 25 single kits each. The product was distributed nationwide in the United States.

The recalled product

Product
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Manufacturer
Neurovision Medical Products Inc
Hazard
  • mis-labeling
  • incorrect-size

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 (1)

  • LOT: 051724B/ UDI: B006LTE7003PS52

Distribution

Distributed nationwide across the United States.