Z-1878-2011

King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems Noblesville, IN...

Name: Z-1878-2011 King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems Noblesville, IN...
Creator: King Systems Corp.
Published: 2011-01-24
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2011-01-24 / Terminated / root cause: supplier

FDA source

King Systems Corp. began a recall of King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems Noblesville, IN. Ventilation during anesthesia during procedures of... on 2011-01-24. The reason FDA records is "The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1878-2011
Status: Terminated
Initiated: 2011-01-24
Posted: 2011-04-04
Terminated: 2012-06-29
Recalling firm: King Systems Corporation.
Product: King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems Noblesville, IN. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare instances the softness of the tube could cause the tube to fold over.
Root cause tag: supplier
FDA root cause: Other
Action: King Systems Corp. sent an URGENT DEVICE RECALL NOTICE letter dated January 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The letters instructed users to cease all sales of the recalled product, to notify the consignees for any product that was further distributed, and to return all recalled product to King Systems. The notice did include a response form. For questions call 317-776-6823, ext 257.
Quantity in commerce: 138 cases 5 units per case, 690 units
Distribution: Worldwide Distribution - USA and Canada
Product codes and lots: IV715

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)