—#121670

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.

FDA product code: CAE — Airway, Oropharyngeal, Anesthesiology
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Part Number KLTD2125 Lot Number I10RG

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: King Systems Corp.
Address: 15011 Herriman Blvd, Noblesville, Indiana 46060-4253

Distribution

Distribution pattern: Distributed in NY.

Timeline

Recall initiated: 2013-09-03
Posted by FDA: 2013-09-19
Terminated: 2014-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121670. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.