FDA-Device2024-01-24Class II
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.
Sarnova HC, Llc
Hazard
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.
Sold states
US Nationwide
Affected count
15 kits
Manufactured in
5000 Tuttle Crossing Blvd, N/A, Dublin, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0721-2024Don't want to check this manually?
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