King Systems Recalls Infant Silicone Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 infant silicone laryngeal airway devices due to potential EtO sterilization indicator failures.
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 a potential failure of the sterilization indicator, which is a labeling/packaging issue regarding verification of sterility, without reported injuries or illnesses.
Plain-English summary
King Systems Corp. is recalling 2,630 units of the KING LAD SILI CONE SINGLE USE, Size 2 / Infant Silicone King LAD. These devices are intended for laryngeal airway use in patients weighing 10-20 kg and are distributed in 263 cases. The recall covers Lot #K120501 (REF: LAD-302) and was 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 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.
Healthcare facilities should stop using the affected devices and contact King Systems Corp. for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg 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-302
- Lot #K120501
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.
See all 10 products in this recall →Related recalls
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