FDAFDA · Food and drugs·Recall number Z-0421-2013
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
Published November 28, 2012 · Recall initiated: November 2, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- King Systems Corp.
- Distributor
- US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
- Lot
- REF: LAD-305, Lot #K120620 and Lot #K120406
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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