Recall Z-1307-2024— Sarnova HC, Llc
Class II · Ongoing
Class II FDA medical device recall by Sarnova HC, Llc, initiated 2024-02-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S. Reason: 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..
- Recalling firm
- Sarnova HC, Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-12
- Firm location
- Dublin, OH, United States
Product description
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.