Medical device recalls Moderate risk

Sarnova HC, Llc recalls Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healt…

Recall date
November 6, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0721-2024
FDA classification
Class II
Brand / firm
Sarnova HC, Llc
Sold / distributed
US Nationwide

Why it was recalled

It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy 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 Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.

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