Device 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 contents.
Z-2255-2013
Product summary
- Event
- Event 66185
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9 cases; 45 products
- Official record key
device-enforcement:Z-2255-2013
Official wording
Reason: 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.
Code information: Part Number KLTD2125 Lot Number I10RG
Distribution pattern: Distributed in NY.
Derived failure modes
-
Unknown
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.