Device product
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
Z-1308-2024
Product summary
- Firm
- Sarnova HC, Llc
- Event
- Event 94116
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 550 units
- Official record key
device-enforcement:Z-1308-2024
Official wording
Reason: 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.
Code information: UDI/GTIN: 00815277020015 each, 00810071639647 case Lot Numbers: ASM0038078 ASM0038130 ASM0038284 ASM0038395
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.