Z-0276-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- September 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36727 units
Product Description
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
UD-DI: 00612649212746 (Shipper Label); 00612649212753 (Piece Label)