Z-0721-2024 Class II Ongoing
FDA device recall Z-0721-2024 was initiated by Sarnova HC, Llc on November 6, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 15 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- November 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 kits
Product 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 for Recall
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.
Distribution Pattern
US Nationwide
Code Information
Lot Numbers: ASM0037685 ASM0037887