Recall Z-1681-2019 ยท CAE Airway, Oropharyngeal, Anesthesiology
King Systems Corp. dba Ambu, Inc.
King LTS-D Kit Size 1, Model Number KLTSD431
| Date | Jan 4, 2019 |
| Status | Terminated |
| Reason | Size 0 products were incorrectly packaged and labeled as a size 1 products. |
| Root cause | Packaging process control |
| Action | Urgent Medical Device Recall notification letters were sent to customers beginning 1/4/19. |
| Quantity | 270 |
| Distribution | The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.