Z-2532-2020 Class II Terminated
FDA device recall Z-2532-2020 was initiated by Bound Tree Medical on May 14, 2020 and is designated Class II. 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 c… The recall status is terminated (terminated December 7, 2023). Affected quantity: 167 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- May 14, 2020
- Termination Date
- December 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167 kits
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
Distribution Pattern
Nationwide Distribution
Code Information
Lot Number: ASM0025699