Z-1308-2024 Class II Ongoing
FDA device recall Z-1308-2024 was initiated by Sarnova HC, Llc on Feb 12, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 550 units.
Recall details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Feb 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 550 units
Product description
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
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.
Distribution pattern
US Nationwide distribution.
Code information
UDI/GTIN: 00815277020015 each, 00810071639647 case Lot Numbers: ASM0038078 ASM0038130 ASM0038284 ASM0038395
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1308-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026