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U.S. Department of Health and Human Services

Class 2 Device Recall King Systems KLTSD414 airway

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 Class 2 Device Recall King Systems KLTSD414 airwaysee related information
Date Initiated by FirmDecember 13, 0013
Date PostedJanuary 10, 2014
Recall Status1 Terminated 3 on May 15, 2014
Recall NumberZ-0709-2014
Recall Event ID 66869
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
ProductKing Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.
Code Information Lot Number(s): I15LB
Recalling Firm/
Manufacturer		 King Systems Corp.
15011 Herriman Blvd
Noblesville IN 46060-4253
For Additional Information ContactWayne Nethercutt
317-776-6823
Manufacturer Reason
for Recall		KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gastric suction tube; the KLTD214 airway does not include a lumen for a gastric suction tube.
FDA Determined
Cause 2		Labeling Change Control
ActionDecember 13, 2013 Urgent Recall Notices were sent to all Direct Accounts identifying the recalled item, risks associated with the incorrectly labeled product and asking customers to stop use, quarantine and destroy any recalled product on hand. Customers were asked to froward the notifcation if the product was further distributed and FAX the completed recall acknowledgement form to 317-776-5175 or email wnethercutt@kingsystems.com. Call the customer service representative (800.262.8673) to arrange for credit of your affected product(s).
Quantity in Commerce108 cases( 540 products)
DistributionDistributed in the states of CA, NY
Total Product Life CycleTPLC 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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