Z-0721-2024 Class II Ongoing
FDA device recall Z-0721-2024 was initiated by Sarnova HC, Llc on Nov 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
- Jan 24, 2024
- Initiation Date
- Nov 6, 2023
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0721-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026