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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
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