Medical device recalls Moderate risk

Sarnova HC, Llc recalls Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergen…

Recall date
February 12, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1307-2024
FDA classification
Class II
Brand / firm
Sarnova HC, Llc
Sold / distributed
US Nationwide distribution.

Why it was recalled

Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

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

What was recalled

Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S

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