King Systems Recalls Child Silicone Laryngeal Airway Devices Due to Sterilization Indicator Defect
King Systems Corp. is recalling 2,630 child silicone laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper EtO sterilization.
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 a sterilization indicator failure suggests the product may not be sterile, posing a risk of infection. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no illnesses or injuries are explicitly stated in the source text.
Plain-English summary
King Systems Corp. is recalling 2,630 units of the KING LAD SILI CONE SINGLE USE, Size 3 / Child Silicone King LAD. The devices are intended for laryngeal airway use in patients weighing 30-50kg and are packaged 10 devices per case. The recall involves 263 cases of product distributed nationwide to facilities in Wisconsin, Texas, New York, Missouri, Indiana, Kentucky, Florida, New Jersey, Pennsylvania, Tennessee, and North Carolina.
The recall was initiated after the firm received two complaints from a user facility in New Jersey. The complaints reported that the color-coded Ethylene Oxide (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. This defect suggests the devices may not have been properly sterilized.
Users should stop using the affected devices immediately. The specific lot number is K120618 and the reference number is LAD-303. Facilities should contact King Systems Corp. for instructions on returning the product.
The recalled product
- Product
- KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone 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-303
- Lot #K120618
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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