Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD· Patient Size: 50-70kg Product Usage: Laryngeal airway |
|---|---|
| Recall Number | Z-0423-2013 |
| Classification | Class II |
| Code Info | REF: LAD-704, Lot #K120412 |
| 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 | |
| Distribution Pattern | US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC |
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