Z-0425-2013Class II

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal...

Name: Z-0425-2013 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal...
Creator: King Systems Corp.
Published: 2012-11-02
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2012-11-02 / Terminated / root cause: manufacturing process

FDA source

King Systems Corp. began a recall of KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD Patient Size: 10-20kg Product... on 2012-11-02. FDA classified it as Class II and gives the reason as "The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0425-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-02
Posted: 2012-11-21
Terminated: 2013-05-28
Recalling firm: King Systems Corporation.
Product: KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD Patient Size: 10-20kg Product Usage: Laryngeal airway
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464.
Quantity in commerce: 263 cases of product. (2,630 devices)
Distribution: US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
Product codes and lots: REF: LAD-902, Lot #K120414

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0425-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0418-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0419-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0420-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0421-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0422-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0423-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0424-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0425-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0426-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21
Z-0427-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

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)