Field Cricothyrotomy Kit Recalled for Incompatible Endotracheal Tube Holder
Sarnova HC is recalling the Curaplex Field Cric Kit due to an incompatible endotracheal tube holder that prevents practitioners from securing the tube during cricothyrotomy procedures. The recall affects 1,063 kits distributed nationwide.
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 is an FDA Class II recall affecting emergency airway management. The functional defect creates a risk of harm during critical procedures, and with no reported injuries or illnesses documented, it qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sarnova HC, Llc is recalling the Curaplex Field Cric Kit with ET Tube (Item Number 36611). The kit is distributed nationwide and includes supplies intended to help healthcare professionals perform a cricothyrotomy, a surgical procedure to establish an emergency airway.
The recall was initiated because the Endotracheal Tube Holder included in the kits is not compatible with the cricothyrotomy procedure. This incompatibility leaves practitioners without the necessary means to properly secure the inserted endotracheal tube.
A total of 1,063 kits are affected under lot numbers ASM0037579, ASM0037631, ASM0037905, and ASM0038197. Healthcare facilities and practitioners who have received these kits should discontinue use and contact Sarnova HC for instructions on replacement or proper handling.
The recalled product
- Product
- Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
- Manufacturer
- Sarnova HC, Llc
- Hazard
- device-malfunction
- equipment-incompatibility
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: ASM0037579 ASM0037631 ASM0037905 ASM0038197
Distribution
Distributed nationwide across the United States.
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