FDAClass IISeptember 4, 2024

Cobra, 3-Plate EMG ET Tube, 6.0mm recall: Labeling Error

Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

Why was Cobra, 3-Plate EMG ET Tube, 6.0mm recalled?

mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOT: 051724B/ UDI: B006LTE7003PS52

Product
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Recalling firm
Neurovision Medical Products Inc
Quantity
5 BOXES (25 single kits)
Distribution
US Nationwide distribution.
Recall date
September 4, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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