King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling specific lots of KING LAD Standard ClearSeal laryngeal airway devices because the ethylene oxide sterilization indicators did not change color as expected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the sterilization indicator failed to change color, creating a risk of using non-sterile equipment. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
King Systems Corp. is recalling 263 cases (2,630 devices) of KING LAD Standard ClearSeal SINGLE USE laryngeal airway devices, Size 3 / Child, Lot #K120411. The recall was initiated after the firm received two complaints from a user facility in New Jersey regarding the color-coded ethylene oxide (EtO) sterilization indicators on the primary device packaging.
The complaints reported that the devices had pink color indicators, whereas the product packaging specified that the color should change from pink to yellow (or brown) if the product had been subjected to EtO sterilization. This discrepancy suggests the sterilization process may not have been properly indicated for the affected units.
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 Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg 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-703
- Lot #K120411
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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