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
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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
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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 |
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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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