Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0418-2013 — 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

U.S. FDA — Device Enforcement · United States · 2012-11-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0418-2013
Date of alert
2012-11-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
King Systems Corp.
Product category
device
Product type
Devices
Reported risk: The 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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