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 Recall Z-1879-2011 · Posted 2011-04-04
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Recalling FirmKing Systems Corp.
Recall StatusTerminated
Product CodeCAE
Date Initiated2011-01-24
Date Terminated2012-06-29
Product Quantity143 cases of 10 each case
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution - USA and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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