Curaplex Cricothyrotomy Field Kit Recalled for Incompatible Tube Holder
Sarnova HC recalls 15 Curaplex Cricothyrotomy Field Kits nationwide due to an incompatible endotracheal tube holder that prevents proper tube securement during cricothyrotomy procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall reports no illnesses or injuries. However, the functional incompatibility in a critical airway management device creates significant risk of harm, meeting the criterion for High severity.
Plain-English summary
Sarnova HC is recalling 15 units of the Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP 6.0mm (Item Number 351631i-A), distributed nationwide. This medical device kit is designed to provide healthcare professionals with supplies needed to perform cricothyrotomy procedures.
The endotracheal tube holder included in certain kits is not compatible with the cricothyrotomy procedure. This incompatibility prevents practitioners from properly securing the inserted endotracheal tube, which is essential for airway management during this critical procedure.
Healthcare facilities that received kits with Lot Numbers ASM0037685 or ASM0037887 should immediately discontinue use of the affected units and contact Sarnova HC for guidance on replacement or corrections. Review any cricothyrotomy procedures performed with these kits to ensure patient safety.
The recalled product
- Product
- 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.
- Manufacturer
- Sarnova HC, Llc
- Hazard
- incompatible-equipment
- airway-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: ASM0037685 ASM0037887
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27