KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use
King Systems Corp. is recalling KING LTSD airway kits (Model KKLTSD4325) because they were marketed for pediatric use without FDA approval for that indication. Approximately 36,727 units were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for exceeding the device's 510(k) exemption by introducing a pediatric indication without proper FDA approval. No deaths, illnesses, or injuries have been reported in the source material.
Plain-English summary
King Systems Corp. dba Ambu, Inc. is recalling the KING LTSD, Size 2.5 with suction port non-sterile kit (Model KKLTSD4325). This oropharyngeal airway is inserted into a patient's mouth through the pharynx to maintain a patent airway. Approximately 36,727 units have been distributed nationwide.
The recall was issued because the device was marketed with an indication for pediatric use that exceeds the scope of its 510(k) exemption under 21 CFR 868.9(a). The device was distributed for use in pediatric patients without obtaining FDA clearance for this expanded indication.
Healthcare facilities and medical professionals who have this product should discontinue use for pediatric indications and follow the FDA recall notice for further guidance.
The recalled product
- Product
- KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Hazard
- unapproved-indication
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: 00612649212746 (Shipper Label)
- 00612649212753 (Piece Label)
Distribution
Distributed nationwide across the United States.
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