Z-0420-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- November 2, 2012
- Termination Date
- May 28, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 263 cases of product. (2,630 devices)
Product Description
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
Reason for Recall
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
Distribution Pattern
US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
Code Information
REF: LAD-304, Lot #K120619