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Terminated

King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, 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-1878-2011 · Posted 2011-04-04

Recalling FirmKing Systems Corp.
Recall StatusTerminated
Product CodeCAE
Date Initiated2011-01-24
Date Terminated2012-06-29
Product Quantity138 cases 5 units per case, 690 units

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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