FDA-Device2013-09-25Class III
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 contents.
King Systems Corp.
Hazard
Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
Sold states
Distributed in NY.
Affected count
9 cases; 45 products
Manufactured in
15011 Herriman Blvd, N/A, Noblesville, IN, United States
Products
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 contents.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2255-2013Don't want to check this manually?
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