—#88832

Product

KING LTS -D, Size 4, 10-0026, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

FDA product code: CAE — Airway, Oropharyngeal, Anesthesiology
Device class: Class 1
Medical specialty: Anesthesiology
510(k) numbers: K021634, K033186
Affected lot / code info: all product produced prior to 12/2009.

Why it was recalled

King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulat

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

On October 29, 2009, the firm, Kings System, sent a "Urgent - Product Correction" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications. Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197. For further information, please call 317-776-6823 ext 257 or email: LTSD@kingsystem.com.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama.

Timeline

Recall initiated: 2009-12-15
Posted by FDA: 2011-01-27
Terminated: 2012-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88832. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.