AMBU King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Indication
King Systems Corp. is recalling AMBU King LTSD oropharyngeal airways because they were marketed for pediatric use without FDA clearance for that indication. The device exceeded its 510(k) exemption limitations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a risk-of-harm situation where the device was marketed with an unvalidated pediatric indication, but actual harm has not been reported.
Plain-English summary
King Systems Corp. is recalling AMBU King LTSD oropharyngeal airways, Size 0/1 with Suction Port (Model KLTSD420), distributed nationwide. These devices are inserted into a patient's pharynx through the mouth to provide airway access.
The recall was initiated because the device was marketed with a new pediatric indication that exceeded the scope of its 510(k) exemption under 21 CFR 868.9(a). The device was not properly cleared by the FDA for use in pediatric patients.
The device may not have been adequately validated for safety and effectiveness in pediatric applications. Healthcare facilities and providers in possession of this device should contact King Systems Corp. for guidance on product disposition and any necessary follow-up.
The recalled product
- Product
- AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
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)
- UDI-DI: 00612649210131 (Shipper Label)
- 00612649210148 (Piece Label)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by King Systems Corp. dba Ambu, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · King Systems Corp. dba Ambu, Inc.
See all →- ModerateKing LTSD Oropharyngeal Airway Recalled for Pediatric Indication Exemption
FDA (Devices) · 2024-11-06
- HighFDA Recalls Pediatric Oropharyngeal Airway Kit for Regulatory Non-Compliance
FDA (Devices) · 2024-11-06
- ModerateKing LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation
FDA (Devices) · 2024-11-06
- HighKing LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Use
FDA (Devices) · 2024-11-06
- HighLaryngeal Tube Device Recalled for Unapproved Pediatric Indication
FDA (Devices) · 2024-11-06
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