AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide paten

FDA device recall Z-0269-2025 · posted 2024-10-30 · Open, Classified

Recall details

Recalling firm

King Systems Corp. dba Ambu, Inc.

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.

Action taken

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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

CAE

Distribution

Nationwide

Date initiated

2024-09-26

Date posted

2024-10-30

Location

Noblesville, IN