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Recall Observatory FDA recall evidence

Device product

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

Z-0274-2025

September 26, 2024

Class II

Product summary

Firm
King Systems Corp. dba Ambu, Inc.
Event
Event 95451
Status
Ongoing
Classification
Class II
Quantity
21591 units
Official record key
device-enforcement:Z-0274-2025

Official wording

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.

Code information: UD-DI: 00612649212708 (Shipper Label); 00612649212715 (Piece Label)

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.