Recall Z-2532-2020— Bound Tree Medical
Class II · Terminated
Class II FDA medical device recall by Bound Tree Medical, initiated 2020-05-14, terminated 2023-12-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.
- Recalling firm
- Bound Tree Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-14
- Terminated
- 2023-12-07
- Firm location
- Dublin, OH, United States
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.