King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled

FDA device recall Z-2255-2013 · posted 2013-09-19 · Terminated

Recall details

Recalling firm

King Systems Corp.

Reason for recall

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.

Action taken

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 wnet@ambu.com. 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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

CAE

Quantity affected

9 cases; 45 products

Distribution

Distributed in NY.

Date initiated

2013-09-03

Date posted

2013-09-19

Date terminated

2014-04-15

Location

Noblesville, IN