King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Use
King Systems' KING LTSD oropharyngeal airway was marketed for pediatric use but lacked the required FDA clearance for that indication. Approximately 17,925 units were distributed nationwide.
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: This is a Class II recall for a medical device with an unapproved indication for pediatric use. While no illnesses or injuries have been reported, marketing an airway device for pediatric patients without FDA clearance for that specific indication represents a risk-of-harm scenario.
Plain-English summary
King Systems Corp. dba Ambu, Inc. is recalling the KING LTSD oropharyngeal airway, Model KLTSD430, Size 0, a non-sterile medical device designed to be inserted through the mouth into the pharynx to maintain a patent airway.
The recall was initiated because the device exceeds the limitations of the 510(k) exemption under 21 CFR 868.9(a). Specifically, the manufacturer introduced a new indication for pediatric use without obtaining FDA clearance for that indication. This means the device was marketed for use in a pediatric population that was not evaluated or approved by the FDA.
Approximately 17,925 units were distributed nationwide. Healthcare providers and patients with this product should cease use and contact King Systems Corp. or Ambu, Inc. for instructions. No illnesses or injuries related to this device have been reported.
The recalled product
- Product
- KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Hazard
- improper-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: 00612649212692 (Shipper Label)
- 00612649212685 (Piece Label)
Distribution
Distributed nationwide across the United States.
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