KING LTS -D, Size 4, 10-0026, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 4

FDA device recall Z-0978-2011 · posted 2011-01-27 · Terminated

Recall details

Recalling firm

King Systems Corp.

Reason for recall

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

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

CAE

Quantity affected

25,000 all products.

Distribution

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

Date initiated

2009-12-15

Date posted

2011-01-27

Date terminated

2012-08-16

Location

Noblesville, IN

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