—#121688

Product

King LTS-D Oropharyngeal Airways Product Usage: The King LTS-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(s): KLTSD415 Lot Number(s): IV1V3

Why it was recalled

On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I

Root cause (FDA determination)

Error in labeling

Action the firm took

King Systems notified the only one (1) consignee who received the affected product of the problem via a customer complaint. Five (5) of the five (5) affected products were destroyed by consignee.

Recalling firm

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

Distribution

Distribution pattern: USA Nationwide Distribution in the state of NY

Timeline

Recall initiated: 0012-12-13
Posted by FDA: 2013-10-01
Terminated: 2013-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121688. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.