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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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
- Category
- Medical Device — Respiratory
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.
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