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
Recall
- Recall Number
- Z-0271-2025
- Event Number
- 95451
- Firm
- King Systems Corp. dba Ambu, Inc.
- FEI Number
- 1824226
- Product Code
- CAE
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- September 26, 2024
- Posted
- October 30, 2024
- Address
- 15011 Herriman Blvd, Noblesville, IN, 46060-4253
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
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.
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 [email protected].
Nationwide
42605 units