King Systems Corp.: Medical Device Recall in 2012 - (Recall #: Z-0424-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

Product Classification:

Class II

Date Initiated: November 2, 2012

Date Posted: November 28, 2012

Recall Number: Z-0424-2013

Event ID: 63580

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

Status: Terminated

Product Quantity: 263 cases of product. (2,630 devices)

Code Information:

REF: LAD-705, Lot #K120413

Distribution Pattern:

US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC

Voluntary or Mandated:

Voluntary: Firm initiated