King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure
King Systems Corp. is recalling 2,630 laryngeal airway devices because sterilization indicators failed to change color, suggesting the devices may not be sterile.
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 is classified as FDA Class II. The hazard involves potential lack of sterility (infection risk) due to failed sterilization indicators, which fits the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
King Systems Corp. is recalling 2,630 units of KING LAD Standard ClearSeal SINGLE USE laryngeal airway devices (Size 4, REF: LAD-704, Lot #K120412). 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 complainant reported that the indicators remained pink, whereas the product packaging specifies that the color should change from pink to yellow or brown if the product was 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. The devices are intended for use in patients weighing 50-70 kg.
Users should stop using the affected devices and contact King Systems Corp. for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal 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-704
- Lot #K120412
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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