FDA recall Z-1307-2024

Sarnova HC, Llc · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-02-12
Report date
2024-03-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1307-2024