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.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide