FDASeptember 26, 2024device
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
king systems corp dba ambukingking systems
UPCs
0061264921019300612649210209
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCLiKee Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by ChilanTech2026-06-11
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