—#97483

Product

King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405, Manufacturer: King Systems Noblesville, IN. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.

FDA product code: CAE — Airway, Oropharyngeal, Anesthesiology
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: 201011-169

Why it was recalled

The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare instances the softness of the tube could cause the tube to fold over.

Root cause (FDA determination)

Other

Action the firm took

King Systems Corp. sent an URGENT DEVICE RECALL NOTICE letter dated January 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The letters instructed users to cease all sales of the recalled product, to notify the consignees for any product that was further distributed, and to return all recalled product to King Systems. The notice did include a response form. For questions call 317-776-6823, ext 257.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA and Canada

Timeline

Recall initiated: 2011-01-24
Posted by FDA: 2011-04-04
Terminated: 2012-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.