King Systems recalls pediatric oropharyngeal airway devices (KLTSD421) due to potential pediatric use risks. Affected units may cause harm if used beyond intended medical applications.
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 their Size 1 oropharyngeal airway devices with suction port for pediatric use. These devices could pose risks if used outside their intended medical purpose, particularly for children.
The device is designed for specific medical use in patients. Using it for pediatric applications beyond its intended purpose could lead to complications if the device doesn't fit properly or function as intended.
Healthcare providers using these devices for medical procedures, especially those treating pediatric patients. Children receiving airway management are at higher risk if the device is misused.
Check for model number KLTSD421 on the device. The unit may have a unique identifier (UDI-DI) starting with 0061264: 00612649210162 (shipper label) or 00612649210155 (piece label).
Look for model number KLTSD421 and unique identifiers starting with 00612649210162 or 00612649210155.
The device is intended for medical use but may pose risks if used beyond its intended purpose, particularly for pediatric patients.
Check the device label for model number KLTSD421 and unique identifiers to confirm if it's affected. No specific action is required if it's not the recalled model.
The recalled model is KLTSD421 with unique identifiers starting with 00612649210162 (shipper label) or 00612649210155 (piece label).
We’ve drafted a message you can send King Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0270-2025 — King Systems King Systems Hello, I own a King Systems that is covered by recall Z-0270-2025 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.
