King LTSD Size 2.5 (King Systems) – Pediatric Use Risk (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
King Systems Corp. dba Ambu, Inc.
Lot Codes / Batch Numbers
UD-DI: 00612649210193 (Shipper Label), 00612649210209 (Piece Label)
Products Sold
UD-DI: 00612649210193 (Shipper Label); 00612649210209 (Piece Label)
King Systems Corp. dba Ambu, Inc. is recalling KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to pr due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
King Systems issued Urgent Field Safety Notice on 9/26/624 via email/Certified Mail. Letter states reason for recall, health risk and action to take: You must discontinue use and dispose of King LTS-D" Disposable Laryngeal Tube pediatric sizes and identify alternative devices for appropriate airway management. Within one month of receipt of this notice, please provide return response for this Field Safety Notice. This Notice needs to be passed on to all those who might concern within your organization where the devices could have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Patient safety remains our highest priority. If you have additional questions regarding this information, please contact your local Ambu-King Systems sales representative. Should you have additional questions, please do not hesitate to contact Tammy Feyerherm at tfey@ambu.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026