The Recall Desk
HighFDA (Devices)·Z-1307-2024·Announced 2024-03-27

Nasal Intubation Kit Recalled for Incompatible Tube Holder

Curaplex Nasal Intubation Kit recalled because the included endotracheal tube holder is incompatible with nasal intubation procedures, preventing practitioners from properly securing the tube.

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: FDA Class II recall of an emergency medical device with a functional incompatibility that prevents safe use. No illnesses or injuries have been reported, placing this within the High category per the rubric criteria for risk-of-harm products without reported injury.

Plain-English summary

Sarnova HC, LLC is recalling the Curaplex Nasal Intubation Kit with 6mm Endotrol Tube (Item 023060S). The endotracheal tube holder included in the kit is not compatible with nasal intubation procedures.

This incompatibility prevents practitioners from properly securing the endotracheal tube during nasal intubation. The kit cannot safely perform its intended function in emergency airway management.

The recall affects 540 kits distributed nationwide. The affected lot numbers are: ASM0038077, ASM0038129, ASM0038334, and ASM0038598.

Affected facilities should identify any inventory matching these lot numbers and remove them from service. Practitioners should not use affected kits for nasal intubation procedures.

The recalled product

Product
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
Manufacturer
Sarnova HC, Llc
Hazard
  • tube-securement-failure
  • 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 (2)

  • UDI/GTIN: 00815277020008 each
  • 00810071639630 case Lot Numbers: ASM0038077 ASM0038129 ASM0038334 ASM0038598

Distribution

Distributed nationwide across the United States.