The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0426-2013·Announced 2012-11-28

King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices

King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to sterilization indicators that failed to change color as expected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential failure of the sterilization indicator, which is a labeling/packaging issue that may indicate a lack of sterilization, but no injuries or illnesses have been reported.

Plain-English summary

King Systems Corp. is recalling 2,630 units of the KING LAD Flexible ClearSeal SINGLE USE laryngeal airway devices. The affected products are Size 3 (Child), intended for patients weighing 30-50 kg, and are ETO sterilized. The recall involves 263 cases of product.

The recall was initiated after the firm received two complaints from a user facility in New Jersey. The complaints reported that the color-coded EtO sterilization indicators on the primary device packaging did not undergo the expected color change. Specifically, the indicators remained pink, whereas the packaging specified they should change from pink to yellow or brown if the product had been subjected to EtO sterilization.

The affected devices were distributed nationwide in the United States, specifically in Wisconsin, Texas, New York, Missouri, Indiana, Kentucky, Florida, New Jersey, Pennsylvania, Tennessee, and North Carolina. The specific reference number is LAD-903 and the lot number is K120416. Users should stop using the affected devices and contact King Systems Corp. for instructions on return or replacement.

The recalled product

Product
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
Manufacturer
King Systems Corp.
Category
Medical Device — Airway Management
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • REF: LAD-903
  • Lot #K120416

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 10 recalled by King Systems Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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