King LTSD Airway Devices Recalled for Unauthorized Pediatric Use Indication

Summary

King Systems Corp. (dba Ambu, Inc.) is recalling 216,999 King LTSD Airway Devices because they contain instructions for use in children that have not been authorized. These devices are inserted through the mouth into a patient's throat to maintain an open airway during medical procedures. While no injuries have been reported, the devices exceed the regulatory limitations for pediatric use. The recall includes various sterile and non-sterile kits in sizes 0 through 2.5.

Risk

Using these medical devices in pediatric patients without specific authorization could lead to improper airway management. Since the safety and effectiveness for children have not been officially cleared for these specific models, there is an increased risk of complications during emergency or surgical airway procedures.

Additional Information