Z-2532-2020Class II

Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu King...

Name: Z-2532-2020 Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu King...
Creator: Bound Tree Medical
Published: 2020-05-14
License: https://open.fda.gov/license/

Bound Tree Medical, LLC / initiated 2020-05-14 / Terminated / root cause: manufacturing process

FDA source

Bound Tree Medical began a recall of 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... on 2020-05-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2532-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-14
Posted: 2020-07-10
Terminated: 2023-12-07
Recalling firm: Bound Tree Medical, LLC
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.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Lot Number: ASM0025699

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2532-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2532-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)