FDAFDA · Food and drugs·Recall number Z-1308-2024
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
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: 00815277020015 each, 00810071639647 case Lot Numbers: ASM0038078 ASM0038130 ASM0038284 ASM0038395
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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