Recall Z-1308-2024 ยท LNZ Changer, Tube, Endotracheal
Sarnova HC, Llc
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
| Date | Mar 19, 2024 (initiated Feb 12, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 550 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.