The Recall Desk
HighFDA (Devices)·Z-2532-2020·Announced 2020-07-15

Bound Tree Medical Recalls Ambu King LTS-D Supraglottic Airway Kits

Bound Tree Medical is recalling 167 Ambu King LTS-D Supraglottic Airway Kits because they contain an incompatible catheter-tip syringe that may prevent the airway balloon from inflating properly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that could prevent the airway from functioning as intended, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Bound Tree Medical is recalling 167 units of the Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube, Part Number KLTSD404K. The affected units are identified by Lot Number ASM0025699 and were distributed nationwide.

The recall was initiated because the kits contained an incorrect catheter-tip syringe that is not compatible with the luer lock connector of the included airway. This incompatibility may result in the inability to inflate the balloons of the supraglottic airway, which is necessary to create a secure seal in the patient's airway as intended.

Healthcare providers and facilities that have received these specific kits should stop using them and contact Bound Tree Medical for further instructions on return or replacement.

The recalled product

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¿
Manufacturer
Bound Tree Medical
Affected units
167

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: ASM0025699

Distribution

Distributed nationwide across the United States.