FDAFDA · Food and drugs·Recall number Z-1307-2024
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
Published March 27, 2024 · Recall initiated: February 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sarnova HC, Llc
- Distributor
- US Nationwide distribution.
- Lot
- UDI/GTIN: 00815277020008 each, 00810071639630 case Lot Numbers: ASM0038077 ASM0038129 ASM0038334 ASM0038598
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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