Class II — King Systems Corp.
| Recalling firm | KING SYSTEMS |
|---|---|
| Registered facility | KING SYSTEMS CORPORATION. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD® Patient Size: >70kg Product Usage: Laryngeal airway |
| Quantity | 263 cases of product. (2,630 devices) |
| Distribution | US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC |
| Initiated | 2012-11-02 |
| Classified | 2012-11-21 |
| Terminated | 2013-05-28 |
| Recall number | Z-0424-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — King Systems Corp. (Z-0424-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63580/
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