Recall Z-0977-2011 ยท CAE Airway, Oropharyngeal, Anesthesiology
King Systems Corp.
KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
| Date | Jan 27, 2011 (initiated Dec 15, 2009) |
| Status | Terminated |
| Reason | 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 | Labeling False and Misleading |
| Action | 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 als |
| Distribution | Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama. |
| FDA record | Open on fda.gov |