Curaplex Nasal Intubation Kit with incompatible tube holder recalled
Sarnova HC is recalling the Curaplex Nasal Intubation Kit because the endotracheal tube holder is incompatible with nasal intubation, preventing practitioners from securing the tube. The recall affects 550 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II recall of emergency airway equipment with a functional defect that prevents proper tube securing during nasal intubation procedures. No illnesses or injuries have been reported, but the defect presents a clear risk in critical emergency care situations.
Plain-English summary
The Curaplex Nasal Intubation Kit with 7mm Endotracheal Tube (Item Number 023070S), manufactured by Sarnova HC, LLC, is being recalled. The endotracheal tube holder included in certain kits is not compatible with nasal intubation procedures, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
The recall affects approximately 550 units distributed nationwide across the United States. Affected lot numbers are ASM0038078, ASM0038130, ASM0038284, and ASM0038395.
This recall affects healthcare facilities and emergency medical services that have received affected kits. The incompatibility prevents proper tube securing during nasal intubation, a critical emergency procedure.
The recalled product
- Product
- Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
- Manufacturer
- Sarnova HC, Llc
- Affected units
- 550
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 (2)
- UDI/GTIN: 00815277020015 each
- 00810071639647 case Lot Numbers: ASM0038078 ASM0038130 ASM0038284 ASM0038395
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sarnova HC, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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