||September 19, 2013
||King LT-D Oropharyngeal Airways
Class 1, 510(k) exempt
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.
||Part Number KLTD2125
Lot Number I10RG
|King Systems Corp.
15011 Herriman Blvd
Noblesville, Indiana 46060-4253
|King Systems is initiating a voluntary recall of an affected lot of its KLTD products shipped on April 30, 2013. King Systems has received a 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 a
||King Systems notified one consignee who received the affected product verbally on August 7, 2013, via email and an Urgent Medical Device Recall - Immediate Action Required notification on September 3, 2013. The Urgent Medical Device Recall - Immediate Action Required notification described the product and issue as well as includes a response form for the consignee to complete and send back to King Systems via FAX to 317-776-5175, or email to firstname.lastname@example.org. Questions regarding the notice are directed to: King Systems customer service representative at 800.642.5464, Monday through Friday 8:00am- 5pm EDT.
For questions regarding this recall call 317-776-6823.
|Quantity in Commerce
||9 cases; 45 products
||Nationwide Distribution including NY