FDA recall Z-0720-2024

Sarnova HC, Llc · Class II · device

Product

Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.

Reason for recall

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.

Distribution

US Nationwide

Key facts

Status
Ongoing
Initiation date
2023-11-06
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0720-2024