Z-0709-2014Class II

King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway...

Name: Z-0709-2014 King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway...
Creator: King Systems Corp.
License: https://open.fda.gov/license/

King Systems Corporation. / Terminated / root cause: labeling and UDI

FDA source

King Systems Corp. began a recall of King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD.... FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0709-2014
Classification: Class II
Status: Terminated
Posted: 2014-01-10
Terminated: 2014-05-15
Recalling firm: King Systems Corporation.
Product: King 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.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: December 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 [email protected]. Call the customer service representative (800.262.8673) to arrange for credit of your affected product(s).
Quantity in commerce: 108 cases( 540 products)
Distribution: Distributed in the states of CA, NY
Product codes and lots: Lot Number(s): I15LB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0709-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0709-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)