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U.S. Department of Health and Human Services

Class 2 Device Recall King LTSD

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 Class 2 Recall
King LTSD
see related information
Date Posted October 01, 2013
Recall Status1 Terminated on November 08, 2013
Recall Number Z-0002-2014
Recall Event ID 66189
Product Classification Airway, Oropharyngeal, Anesthesiology - Product Code CAE
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, Indiana 46060-4253
Consumer Instructions Contact the recalling firm for information
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
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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