FDAFDA · Food and drugs·Recall number Z-0720-2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
Published January 24, 2024 · Recall initiated: November 6, 2023
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
It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy 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
- Lot
- Lot Numbers: ASM0037579 ASM0037631 ASM0037905 ASM0038197
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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