Recall Z-2532-2020 ยท CAE Airway, Oropharyngeal, Anesthesiology
Bound Tree Medical
Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu King LTS-D" Supraglottic Airway.
| Date | May 14, 2020 |
| Status | Terminated |
| Reason | Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of the included airway. As a result, may be unable to inflate the balloons of the supraglottic airway to create a secure seal in the patient s airway as intended by the kit |
| Root cause | Process control |
| Action | The firm, Bound Tree, issued "URGENT NOTICE OF RECALL" letter by mail on May 14, 2020 and Bound Tree Customer Service and followed with email or telephone calls. Letter states reason for recall and action to take: Please immediately physically review your inventory of this kit and lot number for the affected syringe . Should you determine your inventory contains affected product, please quarantine affected kits immediately and contact Boundtree customer care to return product for replacement or credit. Questions pertaining to the recall, you may contact Boundtree customer care at 800-533-0 |
| Quantity | 167 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.