FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0721-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0721-2024
- Event ID
- 93665
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Sarnova HC, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- November 6, 2023
- Classification Date
- January 12, 2024
- Address
- 5000 Tuttle Crossing Blvd, N/A, Dublin, OH, 43016-1534, United States
Description
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.
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 Info
Lot Numbers: ASM0037685 ASM0037887
Distribution
US Nationwide
Quantity
15 kits