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FDA-Device2013-10-09Class IIMISBRANDING

King LTS-D Oropharyngeal Airways recalled for incorrect size labeling

King Systems
LABEL MIX UPNationwide distribution

Check King LTS-D airway size labeling

King Systems recalled one case (5 units) of King LTS-D Oropharyngeal Airways from lot IV1V3 because the package label said size 5, but the actual airway inside was size 4. Using the wrong size airway during anesthesia could affect how well it works for the patient.

  • If you have King LTS-D airways from lot IV1V3, verify the actual airway size matches the package label before use
  • Do not use if the label says size 5 but the airway is size 4
  • Contact King Systems or your supplier if you have affected product
Hazard

On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I

Sold states
USA Nationwide Distribution in the state of NY
Affected count
1 case; 5 units
Manufactured in
15011 Herriman Blvd, Noblesville, IN, United States
Products
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 aspiration of stomach contents.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2014

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