Recall Z-0274-2025 ยท CAE Airway, Oropharyngeal, Anesthesiology
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
| Date | Oct 30, 2024 (initiated Sep 26, 2024) |
| Status | Open, Classified |
| Reason | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| Root cause | No Marketing Application |
| Action | King Systems issued Urgent Field Safety Notice on 9/26/624 via email/Certified Mail. Letter states reason for recall, health risk and action to take: You must discontinue use and dispose of King LTS-D" Disposable Laryngeal Tube pediatric sizes and identify alternative devices for appropriate airway management. Within one month of receipt of this notice, please provide return response for this Field Safety Notice. This Notice needs to be passed on to all those who might concern within your organization where the devices could have been transferred. Please transfer this notice to other organiza |
| Quantity | 21591 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.