Device product
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.
Z-0721-2024
Product summary
- Firm
- Sarnova HC, Llc
- Event
- Event 93665
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 kits
- Official record key
device-enforcement:Z-0721-2024
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: ASM0037685 ASM0037887
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.