KING LAD Flexible ClearSeal SINGLE USE — Class II medical device recall Z-0426-2013
Terminated recall by King Systems Corp., reported 2012-11-28, distributed nationwide. The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization in
| Recall number | Z-0426-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | King Systems Corp., Noblesville, IN, United States |
| Recall initiated | 2012-11-02 |
| Classified | 2012-11-21 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-05-28 |
| Distributed | Nationwide (US) |
| Lot numbers | K120416 |
| Model numbers | LAD-903 |
Product
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0426-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.