Reported Jul 15, 2020 · Terminated
Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D"…
Bound Tree Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bound Tree Medical · 5000 Tuttle Crossing Blvd · Dublin, OH · 43016-1534
Is this the product you have?
- Curaplex Ambu King LTS-D Supraglottic
- Airway Kit with ET Tube Part NumberKLTSD404K 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
- Lot codes and dates
- Lot NumberASM0025699
- Amount recalled
- 167 kits
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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