King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to EtO sterilization indicators that failed to change color.
What this means for you
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 potential sterilization failure indicated by packaging indicators, which is a significant quality issue but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
King Systems Corp. is recalling 263 cases (2,630 devices) of KING LAD Flexible ClearSeal SINGLE USE laryngeal airway devices. The affected product is Size 4 / Adult, intended for patients weighing 50-70kg, and is ETO sterilized. The recall involves Lot #K120417 with REF: LAD-904.
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 product was distributed nationwide in the United States, including Wisconsin, Texas, New York, Missouri, Indiana, Kentucky, Florida, New Jersey, Pennsylvania, Tennessee, and North Carolina. Users should stop using the affected devices and contact King Systems Corp. for further instructions.
The recalled product
- Product
- KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
- Manufacturer
- King Systems Corp.
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-904
- Lot #K120417
Distribution
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.
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