Z-2255-2013Class III

King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for...

Name: Z-2255-2013 King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for...
Creator: King Systems Corp.
Published: 2013-09-03
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2013-09-03 / Terminated / root cause: labeling and UDI

FDA source

King Systems Corp. began a recall of King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for... on 2013-09-03. FDA classified it as Class III and gives the reason as "Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size...". 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-2255-2013
Classification: Class III
Status: Terminated
Initiated: 2013-09-03
Posted: 2013-09-19
Terminated: 2014-04-15
Recalling firm: King Systems Corporation.
Product: King LT-D Oropharyngeal Airways The King LT-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: Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: King Systems notified one consignee who received the affected product verbally on August 7, 2013, via email and an Urgent Medical Device Recall - Immediate Action Required notification on September 3, 2013. The Urgent Medical Device Recall - Immediate Action Required notification described the product and issue as well as includes a response form for the consignee to complete and send back to King Systems via FAX to 317-776-5175, or email to [email protected]. Questions regarding the notice are directed to: King Systems customer service representative at 800.642.5464, Monday through Friday 8:00am- 5pm EDT. For questions regarding this recall call 317-776-6823.
Quantity in commerce: 9 cases; 45 products
Distribution: Distributed in NY.
Product codes and lots: Part Number KLTD2125 Lot Number I10RG

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2255-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2255-2013	Class III	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-19

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)