Medical device recalls Moderate risk

Cobra recalled over labeling errors

Recall date
July 1, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Neurovision Medical Products Inc recalls Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Recall number
Z-2719-2024
FDA classification
Class II
Brand / firm
Neurovision Medical Products Inc
Sold / distributed
US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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