Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professiona...
FDA Device Recall #Z-0720-2024 — Class II — November 6, 2023
Recall Summary
| Recall Number | Z-0720-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 6, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sarnova HC, Llc |
| Location | Dublin, OH |
| Product Type | Devices |
| Quantity | 1063 kits |
Product Description
Curaplex Field Cric Kit with ET Tube, Item Number 36611. 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
Lot / Code Information
Lot Numbers: ASM0037579 ASM0037631 ASM0037905 ASM0038197
Other Recalls from Sarnova HC, Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1308-2024 | Class II | Curaplex Nasal Intubation Kit w/ 7mm Endotrache... | Feb 12, 2024 |
| Z-1307-2024 | Class II | Curaplex Nasal Intubation Kit with 6mm Endotrol... | Feb 12, 2024 |
| Z-0721-2024 | Class II | Curaplex Cricothyrotomy Field Kit with Instrume... | Nov 6, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.