King LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication
King Systems is recalling the King LTSD Size 2 oropharyngeal airway because it was distributed with a pediatric indication that lacks proper FDA 510(k) clearance, exceeding exemption limits.
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 a Class II device being distributed with a pediatric use indication that lacks proper 510(k) clearance, representing a risk-of-harm situation for a critical airway device. No illnesses or injuries have been reported.
Plain-English summary
King Systems Corp. dba Ambu, Inc. is recalling the King LTSD Size 2 with Suction Port Non-Sterile Kit nationwide. This oropharyngeal airway is inserted into the patient's pharynx through the mouth to provide and maintain a patent airway.
The recall is due to a regulatory violation: the device was distributed with an indication for pediatric use that exceeds the limitations of the 510(k) exemption under 21 CFR 868.9(a). The device's 510(k) clearance did not include evaluation for this pediatric use indication.
Approximately 44,755 units have been distributed nationwide. The affected units can be identified by Universal Device Identifier (UDI) codes UD-DI: 00612649212722 (Shipper Label) and 00612649212739 (Piece Label).
Healthcare providers and facilities using this device should contact King Systems Corp. dba Ambu, Inc. for instructions and further information regarding this recall.
The recalled product
- Product
- KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Hazard
- Affected units
- 44,755
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: 00612649212722 (Shipper Label)
- 00612649212739 (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 Kit Recalled for Unapproved Pediatric Use
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
Similar recalls
- ModerateKing Systems Recalls Mislabelled Oropharyngeal Airways Due to Size Error
FDA (Devices) · 2013-10-09
- LowKing LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error
FDA (Devices) · 2013-09-25
- HighKing Systems Recalls Supraglottic Airway Kits Due to Incorrect Component
FDA (Devices) · 2014-01-22
- ModerateKing Systems Recalls Infant Silicone Laryngeal Airway Devices
FDA (Devices) · 2012-11-28
- ModerateKing Systems Recalls Infant Laryngeal Airway Devices Due to Sterilization Indicator Issues
FDA (Devices) · 2012-11-28
- HighKing Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure
FDA (Devices) · 2012-11-28