The Recall Desk
LowFDA (Devices)·Z-2255-2013·Announced 2013-09-25

King LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error

King Systems Corp. is recalling King LT-D Oropharyngeal Airways because size 5 units were packaged in pouches labeled as size 2.5.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a packaging labeling error where the physical product is clearly marked with the correct size, making it unlikely to cause adverse health consequences.

Plain-English summary

King Systems Corp. is recalling 45 King LT-D Oropharyngeal Airways (Part Number KLTD2125, Lot Number I10RG) due to a packaging labeling error. The recall involves size 5 airways that were packaged in pouches indicating a size of 2.5. The correct size is clearly marked on the actual airway product, and the physical size difference between the two is distinct and obvious.

The affected products were distributed in New York. The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for short-duration procedures when the patient is considered to have a low risk of aspiration of stomach contents.

Healthcare facilities should check their inventory for these specific units. Although the packaging label is incorrect, the physical product is clearly marked with the correct size, allowing for visual verification.

The recalled product

Product
King LT-D Oropharyngeal Airways The King LT-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 aspiration of stomach conten
Manufacturer
King Systems Corp.

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 KLTD2125 Lot Number I10RG

Distribution

Distributed in 1 state: