| | Class 2 Recall
KING LAD SILI CONE |  |
| Date Posted |
November 21, 2012 |
| Recall Number |
Z-0419-2013 |
| Product |
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile
Size 3 / Child Silicone King LAD® Patient Size: 30-50kg
Product Usage:
Laryngeal airway |
| Code Information |
REF: LAD-303, Lot #K120618
|
Recalling Firm/
Manufacturer |
King Systems Corp.
15011 Herriman Blvd
Noblesville, Indiana 46060 |
| Consumer Instructions |
Contact the recalling firm for information |
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
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| Action |
King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464. |
| Distribution |
US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC |
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