King Systems Corp. Cardiac ResQ Kit, Size 5, CRQ425, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cardiac ResQ Kit, Size 5, CRQ425, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
Brand
King Systems Corp.
Lot Codes / Batch Numbers
all products produced prior to 12/2009.
Products Sold
all products produced prior to 12/2009.
King Systems Corp. is recalling Cardiac ResQ Kit, Size 5, CRQ425, King Systems Corporation 15011 Herriman Boulevard, Noblesville, I due to King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning l. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026