King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling 2,630 adult silicone King LAD devices because sterilization indicators failed to change color as expected.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is limited to a potential sterilization indicator failure, which fits the criteria for a moderate severity score involving low-risk contamination or labeling/indicator issues without reported harm.
Plain-English summary
King Systems Corp. is recalling 2,630 units of the King LAD SILI CONE SINGLE USE, Size 4 / Adult Silicone King LAD. The affected devices are distributed in 10 cases per box and are ETO sterile. The recall covers 263 cases, totaling 2,630 devices, with a reference number of LAD-304 and Lot #K120619.
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 products were distributed nationwide in the United States, specifically in 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 SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
- 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-304
- Lot #K120619
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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