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U.S. Department of Health and Human Services

Class 2 Device Recall Curaplex Ambu King LTSD" Supraglottic Airway Kit with ET Tube. Bound

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  Class 2 Device Recall Curaplex Ambu King LTSD" Supraglottic Airway Kit with ET Tube. Bound see related information
Date Initiated by Firm May 14, 2020
Create Date July 10, 2020
Recall Status1 Terminated 3 on December 07, 2023
Recall Number Z-2532-2020
Recall Event ID 85832
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube
Part Number: KLTSD404K

Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu¿ King LTS-D" Supraglottic Airway.
Code Information Lot Number: ASM0025699  
Recalling Firm/
Manufacturer		 Bound Tree Medical
5000 Tuttle Crossing Blvd
Dublin OH 43016-1534
Manufacturer Reason
for Recall		 Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of the included airway. As a result, may be unable to inflate the balloons of the supraglottic airway to create a secure seal in the patient s airway as intended by the kit
FDA Determined
Cause 2		 Process control
Action The firm, Bound Tree, issued "URGENT NOTICE OF RECALL" letter by mail on May 14, 2020 and Bound Tree Customer Service and followed with email or telephone calls. Letter states reason for recall and action to take: Please immediately physically review your inventory of this kit and lot number for the affected syringe . Should you determine your inventory contains affected product, please quarantine affected kits immediately and contact Boundtree customer care to return product for replacement or credit. Questions pertaining to the recall, you may contact Boundtree customer care at 800-533-0523.
Quantity in Commerce 167 kits
Distribution Nationwide Distribution
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.
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