FDA Device recall Z-1307-2024
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency by Sarnova Hc, citing 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 end….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1307-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-12 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sarnova Hc |
| Distribution | US |
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.
Identifiers
| code_info | UDI/GTIN: 00815277020008 each, 00810071639630 case Lot Numbers: ASM0038077 ASM0038129 ASM0038334 ASM0038598 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1307-2024%22
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