FDA Enforcement
Class II
Ongoing
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
Recall: Z-1307-2024
·
Reported March 27, 2024
Enforcement
- Recall Number
- Z-1307-2024
- Event ID
- 94116
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Sarnova HC, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 27, 2024
- Initiation Date
- February 12, 2024
- Classification Date
- March 19, 2024
- Address
- 5000 Tuttle Crossing Blvd, Dublin, OH, 43016-1534, United States
Description
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
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 Info
UDI/GTIN: 00815277020008 each, 00810071639630 case Lot Numbers: ASM0038077 ASM0038129 ASM0038334 ASM0038598
Distribution
US Nationwide distribution.
Quantity
540 kits