Z-0002-2014Class II

King LTS-D Oropharyngeal Airways

Name: Z-0002-2014 King LTS-D Oropharyngeal Airways
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 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.... FDA classified it as Class II and gives the reason as "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...". 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-0002-2014
Classification: Class II
Status: Terminated
Posted: 2013-10-01
Terminated: 2013-11-08
Recalling firm: King Systems Corporation.
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.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Part Number(s): KLTSD415 Lot Number(s): IV1V3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0002-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0002-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-10-01

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)