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U.S. Department of Health and Human Services

Class 3 Device Recall King LTD Oropharyngeal Airways

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  Class 3 Device Recall King LTD Oropharyngeal Airways see related information
Date Initiated by Firm September 03, 2013
Date Posted September 19, 2013
Recall Status1 Terminated 3 on April 15, 2014
Recall Number Z-2255-2013
Recall Event ID 66185
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product King LT-D Oropharyngeal Airways

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.
Code Information Part Number KLTD2125 Lot Number I10RG
Recalling Firm/
Manufacturer		 King Systems Corp.
15011 Herriman Blvd
Noblesville IN 46060-4253
For Additional Information Contact
317-776-6823
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action King Systems notified one consignee who received the affected product verbally on August 7, 2013, via email and an Urgent Medical Device Recall - Immediate Action Required notification on September 3, 2013. The Urgent Medical Device Recall - Immediate Action Required notification described the product and issue as well as includes a response form for the consignee to complete and send back to King Systems via FAX to 317-776-5175, or email to wnet@ambu.com. Questions regarding the notice are directed to: King Systems customer service representative at 800.642.5464, Monday through Friday 8:00am- 5pm EDT. For questions regarding this recall call 317-776-6823.
Quantity in Commerce 9 cases; 45 products
Distribution Distributed in NY.
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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