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U.S. Department of Health and Human Services

Class 2 Device Recall King LTD Oropharyngeal Airway

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  Class 2 Device Recall King LTD Oropharyngeal Airway see related information
Date Initiated by Firm January 24, 2011
Date Posted April 04, 2011
Recall Status1 Terminated 3 on June 29, 2012
Recall Number Z-1878-2011
Recall Event ID 57810
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product 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.
Code Information IV715
Recalling Firm/
Manufacturer		 King Systems Corp.
15011 Herriman Blvd
Noblesville IN 46060
For Additional Information Contact Tony Barbour
317-776-6823
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 138 cases 5 units per case, 690 units
Distribution Worldwide Distribution - USA and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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