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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description 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
Recall Number Z-0419-2013
Classification Class II
Code Info REF: LAD-303, Lot #K120618
Product Distributed Qty 263 cases of product. (2,630 devices)
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 sterilization cycle. The firms investigation revealed that the complainant claims were confirmed; the firm then performed a 100% inspection of all product supplied by Three Lions Ltd. The firm segregated the affected lots of King LAD devices.

Event Detail

Event Id 63580
Product Type Devices
Status Ongoing
Recalling Firm King Systems Corp.
City Noblesville
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-02
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC