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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 66185
Product Type Devices
Status Ongoing
Recalling Firm King Systems Corp.
City Noblesville
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-03
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in NY.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
King LT-D Oropharyngeal Airways Class 1, 510(k) exempt The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. Part Number KLTD2125 Lot Number I10RG Class III King Systems is initiating a voluntary recall of an affected lot of its KLTD products shipped on April 30, 2013. King Systems has received a report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious. King Systems has received no reports of serious injuries or deaths resulting from this issue. 9 cases; 45 products Z-2255-2013