Device Recall KING LT D Laryngeal Tube 의 리콜

Recall

54350

Class 2

Z-0984-2011

2009-12-15

2011-01-27

Terminated

United States

2012-08-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88838

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.

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.