Recall Z-0271-2025— King Systems Corp. dba Ambu, Inc.
Class II · Ongoing
Class II FDA medical device recall by King Systems Corp. dba Ambu, Inc., initiated 2024-09-26. FDA's recall record names no specific 510(k) clearance for this event. Product: KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422. Reason: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway..
- Recalling firm
- King Systems Corp. dba Ambu, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-26
- Firm location
- Noblesville, IN, United States
Product description
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
Reason for recall
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Data sourced from openFDA. This site is unofficial and independent of the FDA.