FDA Recalls Pediatric Oropharyngeal Airway Kit for Regulatory Non-Compliance
King Systems Corp. is recalling 21,591 KING LTSD airway kits nationwide. The devices were distributed with an unauthorized indication for pediatric use that exceeds FDA regulatory authorization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recalled due to regulatory non-compliance—unauthorized pediatric indication exceeds 510(k) exemption scope. Although no illnesses or injuries have been reported, this is a risk-of-harm product (critical-function airway device) distributed for a population without proper regulatory authorization.
Plain-English summary
The KING LTSD, Size 1, with suction port (non-sterile kit), Model KLTSD431, is an oropharyngeal airway device inserted into a patient's pharynx through the mouth to provide a patent airway. King Systems Corp., operating as Ambu, Inc., is recalling 21,591 units distributed nationwide.
The recall was issued because the device was marketed with a new indication for pediatric use that exceeds the limitations of the 510(k) regulatory exemption under 21 CFR 868.9(a). The device's regulatory authorization does not include this pediatric indication.
Affected devices can be identified by lot codes UD-DI 00612649212708 (shipper labels) or UD-DI 00612649212715 (piece labels). Healthcare professionals, patients, and individuals in possession of recalled devices should verify whether they have affected units.
The recalled product
- 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
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Hazard
- unapproved-indication
- regulatory-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UD-DI: 00612649212708 (Shipper Label)
- 00612649212715 (Piece Label)
Distribution
Distributed nationwide across the United States.
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