King Systems recalls pediatric oropharyngeal airway kits for potential pediatric use risks. Learn about affected models and safety steps.
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
King Systems recalls certain pediatric oropharyngeal airway kits due to a risk of improper use in children. This could lead to airway blockage if not used correctly.
The kit was designed for adult use but may be used in children without proper medical supervision. This could cause airway blockage or breathing difficulties if not used correctly.
Parents and caregivers of children who use these airways for medical purposes. Children with breathing difficulties are at higher risk.
Check for model number KLTSD430 on the kit. The shipper label starts with 00612649212692 and the piece label starts with 00612649212685.
Look for model number KLTSD430 on the kit label.
Reach out to King Systems for guidance on safe use or alternatives.
The recall indicates it was intended for adult use but may be used in children. Proper medical supervision is required.
Check the model number and contact King Systems for guidance on safe use or alternatives.
Look for model number KLTSD430 on the kit. The shipper label starts with 00612649212692 and the piece label starts with 00612649212685.
We’ve drafted a message you can send King Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0273-2025 — King Systems King Systems Hello, I own a King Systems that is covered by recall Z-0273-2025 from King Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
