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King Systems Corp. Recall: KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Steril

King Systems Corp. Recall: KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Steril is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: King Systems Corp.; Product: KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible

Recalling firmKing Systems Corp.
ProductKING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
Reason for recallThe firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionUS Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
Recall initiated20121102
Recall numberZ-0426-2013
Categorydevice
StateIN
CountryUnited States

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