FDA-Device2012-11-28Class II
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
King Systems Corp.
Hazard
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
Sold states
US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
Affected count
263 cases of product. (2,630 devices)
Manufactured in
15011 Herriman Blvd, N/A, Noblesville, IN, United States
Products
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2013Don't want to check this manually?
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