King Systems Recalls Mislabelled Oropharyngeal Airways Due to Size Error
King Systems Corp. is voluntarily recalling one case of King LTS-D Oropharyngeal Airways because the package label incorrectly identified the size.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall involving a minor labeling error (size misidentification) with no reported injuries or illnesses, fitting the criteria for a Moderate severity score.
Plain-English summary
King Systems Corp. initiated a voluntary recall of one case containing five individual King LTS-D Oropharyngeal Airways on December 13, 2012. The recall involves a specific lot (IV1V3) and part number (KLTSD415).
The reason for the recall is a labeling error: the package label indicated that the airway was a size 5, but the actual airway inside the package was a size 4. The King LTS-D is intended for use in adult patients for controlled ventilation during anesthesia.
The affected products were distributed nationwide in the United States, specifically within the state of New York. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of…
- Manufacturer
- King Systems Corp.
- Hazard
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)
- Part Number(s): KLTSD415 Lot Number(s): IV1V3
Distribution
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