King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation
King Systems Corp. is recalling 31,457 units of King LTSD oropharyngeal airways because the device exceeded 510(k) exemption limitations by introducing a new pediatric indication.
- Product
- KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
- Category
- Medical Device
- Distribution
- Distributed nationwide