Z-0270-2025 Class II Ongoing
FDA device recall Z-0270-2025 was initiated by King Systems Corp. dba Ambu, Inc. on September 26, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 21939 units.
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
- 21939 units
Product Description
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
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
UDI-DI: 00612649210162 (Shipper Label); 00612649210155 (Piece Label)