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King Systems Corp. dba Ambu, Inc. recalls KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.
Recalled November 6, 2024 · FDA recall Z-0270-2025 · King Systems Corp.
Hazard
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. · FDA Class II
Units
21939 units
Sold at
Nationwide
Description
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.
Product
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
Manufacturer(s)
King Systems Corp. dba Ambu, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →