Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emerge
FDA device recall Z-1308-2024 · posted 2024-03-19 · Open, Classified
Recall details
- Recalling firm
- Sarnova HC, Llc
- 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.
- Action taken
- Bound Tree issued URGENT NOTICE OF RECALL letters on February 12, 2024 via USPS Letter to Medical Inventory Controls/Supplies Coordinator/Buyer. Letter states reason for recall, health risk and actin to take: Should you determine your inventory contains product covered by this recall, please immediately quarantine your affected product and contact Bound Tree Medical Customer Care at 800.533.0523 to arrange for a return of the product in exchange for a credit
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- LNZ
- Quantity affected
- 550 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-02-12
- Date posted
- 2024-03-19
- Location
- Dublin, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.