Class 2 Device Recall King LTSD Kit Size 1

• Date Initiated by Firm: January 04, 2019
• Create Date: May 29, 2019
• Recall Status: Terminated on April 20, 2020
• Recall Number: Z-1681-2019
• Recall Event ID: 82036
• Product Classification: Airway, oropharyngeal, anesthesiology - Product Code CAE
• Product: King LTS-D Kit Size 1, Model Number KLTSD431
• Code Information: Lot code 1000147351
• FEI Number: 1824226
• Recalling Firm/ Manufacturer: King Systems Corp. dba Ambu, Inc.; 15011 Herriman Blvd; Noblesville IN 46060-4253
• For Additional Information Contact: King Systems Customer Service; 317-776-6823
• Manufacturer Reason for Recall: Size 0 products were incorrectly packaged and labeled as a size 1 products.
• FDA Determined Cause: Packaging process control
• Action: Urgent Medical Device Recall notification letters were sent to customers beginning 1/4/19.
• Quantity in Commerce: 270
• Distribution: The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
• Total Product Life Cycle: TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.