Date Initiated by Firm |
December 13, 0012 |
Date Posted |
October 01, 2013 |
Recall Status1 |
Terminated 3 on November 08, 2013 |
Recall Number |
Z-0002-2014 |
Recall Event ID |
66189 |
Product Classification |
Airway, oropharyngeal, anesthesiology - Product Code CAE
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Product |
King LTS-D Oropharyngeal Airways
Product Usage: The King LTS-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(s): KLTSD415 Lot Number(s): IV1V3 |
Recalling Firm/ Manufacturer |
King Systems Corp. 15011 Herriman Blvd Noblesville IN 46060-4253
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For Additional Information Contact |
317-776-6823
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Manufacturer Reason for Recall |
On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I
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FDA Determined Cause 2 |
Error in labeling |
Action |
King Systems notified the only one (1) consignee who received the affected product of the problem via a customer complaint. Five (5) of the five (5) affected products were destroyed by consignee. |
Quantity in Commerce |
1 case; 5 units |
Distribution |
USA Nationwide Distribution in the state of NY |
Total Product Life Cycle |
TPLC Device Report
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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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