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.
Z-0720-2024
Product summary
- Firm
- Sarnova HC, Llc
- Event
- Event 93665
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1063 kits
- Official record key
device-enforcement:Z-0720-2024
Official wording
Reason: 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.
Code information: Lot Numbers: ASM0037579 ASM0037631 ASM0037905 ASM0038197
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.