• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall KING LTSD KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall KING LTSD KITsee related information
Date Initiated by FirmSeptember 26, 2024
Date PostedOctober 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0270-2025
Recall Event ID 95451
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
ProductKING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
Code Information UDI-DI: 00612649210162 (Shipper Label); 00612649210155 (Piece Label)
Recalling Firm/
Manufacturer
King Systems Corp. dba Ambu, Inc.
15011 Herriman Blvd
Noblesville IN 46060-4253
For Additional Information ContactSanjay Parikh
1-800-2628462
Manufacturer 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.
FDA Determined
Cause 2
No Marketing Application
ActionKing 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.
Quantity in Commerce21939 units
DistributionNationwide
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-